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Prevention of Peritonitis in Peritoneal Dialysis

Prevention of Peritonitis in Patients With Peritoneal Dialysis - Effects of Regular Follow-up of Patients´ Theoretical Knowledge and Practical Skills With Focus on Infection Prophylaxis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01293799
Acronym
PEPS
Enrollment
713
Registered
2011-02-11
Start date
2010-01-31
Completion date
2015-12-31
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis Capd Infection, Kidney Failure, Chronic, Peritoneal Dialysis-associated Peritonitis

Keywords

Randomized, Peritoneal dialysis, Peritonitis, Primary prevention, Quality control, Self care, Kidney failure, chronic

Brief summary

BACKGROUND: Peritonitis remains a significant problem in peritoneal dialysis (PD). It is the leading cause of technique failure, and contributes to mortality. The incidence is highest during the first year of treatment. Non-compliance with the PD protocol is shown to be an important risk factor for peritonitis. Reinforcement of knowledge and ability to perform PD therefore appears to be a possible way to reduce the incidence of peritonitis. This will be studied in The PEritonitis Prevention Study (PEPS). METHODS: The objective of this randomized, multi-centre investigation, which will include 750 new PD patients who can perform (PD) without assistance, is to evaluate if regular retraining can reduce the incidence of peritonitis, the technique-failure rate, and the hospitalisation days due to peritonitis compared with regular follow-up regimen. Patients in the intervention group will be tested by a PD-technique test and a questionnaire at regular intervals after PD-start and after every peritonitis episode with focus on infection prophylaxis. If needed, they will be retrained. The control group will be treated according to the routine of the center. The study is ongoing in Denmark, Norway, Sweden, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom (UK). The study will go on for 6 years.

Detailed description

BACKGROUND See above. AIMS The primary aim of this trial is to study if regular follow-up of PD patients with testing of their theoretical and practical knowledge (hereafter called new type of follow-up) can reduce the time to first peritonitis episode. Secondary aims were to study if the new type of follow-up could reduce the incidence of peritonitis, the technique failure rate related to peritonitis, and the time of hospitalization related to peritonitis compared to a routine regimen. For specific aims, see Outcome measures below. A further aim was to study risk factors for peritonitis. PATIENTS AND METHODS The study is a randomized, multi-centre investigation intending to enclose 750 new PD patients in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom. Inclusion was finished on December 31, 2014. The study will go on until the last included patient has taken part of the study for one year. The study will thus be terminated on December 31, 2015. The study includes a retraining group and a control group. The intervention in the retraining group consists of regular testing of theoretical and practical knowledge regarding PD with focus on infection prophylaxis including retraining if needed until the test goals are reached. The control group will be treated according to the routines of the center. Peritonitis is defined according to International Society for Peritoneal Dialysis (SPD) guidelines (Peritoneal Dialysis International 2005;25:107-131) The baseline PD training will be the same at all participating centres and follow international recommendations. In addition, fluorescent alcohol and a UV lamp will be used to control the result of hand disinfection in all patients once during the initial PD training. Thereafter this method will only be used in the retraining group.. In the retraining group, the knowledge from the basal training will be tested at 1, 3, 6, and 12 months after PD start, every sixth month thereafter, and after every episode of peritonitis. Such testing will also be performed at restart of PD and includes two types of tests: 1. The patient will fill in a questionnaire with theoretical and practical questions with focus on infection and infection prophylaxis during PD treatment. Goal: At least 80% of the questions should be correct. If the goal is not reached, further training will be given until the goal is reached. 2. The patient will perform a practical test including hand disinfection, PD exchange technique, and exit-site care. Hand disinfection skills will be controlled with the help of fluorescent alcohol and a UV lamp. Goal: All steps of the practical test should be correctly performed. If not, further training will be given until the goal is reached.

Interventions

BEHAVIORALRetraining

Testing of the patients´ knowledge and retraining will be given if needed

Sponsors

Odense University Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Sykehuset Innlandet HF
CollaboratorOTHER
Tampere University Hospital
CollaboratorOTHER
Pauls Stradins Clinical University Hospital
CollaboratorOTHER
Tartu University Hospital
CollaboratorOTHER
Karolinska Institutet
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
Sheffield Teaching Hospitals NHS Foundation Trust
CollaboratorOTHER
Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A non-commercial, physician-initiated, randomized, controlled, open-label, parallel-group, multicenter clinical trial. The participants were randomly assigned to either retraining with testing of their peritoneal dialysis knowledge (the retraining group) or to usual care (the control group).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient is able to perform PD without assistance * Age 18 years old or more

Exclusion criteria

* Previous PD-treatment less than 2 years ago * Peritonitis before inclusion * Active malignancy * Participation in other studies during the study period which may affect outcome of the present study

Design outcomes

Primary

MeasureTime frameDescription
Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control GroupParticipants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.

Secondary

MeasureTime frameDescription
Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining GroupThe participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. The time in study was calculated for each participantThe incidence of a first peritonitis episode is expressed as the mean rate of a first peritonitis per patient year (event rate) with 95% confidence interval.
Incidence of All Peritonitis Episodes in the Control Group and the Retraining GroupThe participants were followed from 1 month after PD start (time of randomization) up to 36 months after start of peritoneal dialysis, The time (days) of participation in the study was calculated for each participant.The incidence of peritonitis episodes is expressed as the mean rate of peritonitis per patient year (event rate) with 95% confidence interval.

Other

MeasureTime frameDescription
Analysis of Body Weight in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for body weight at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Body Mass Index in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for body mass index at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Diabetic Nephropathy as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Diabetic nephropathy as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Glomerulonephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Glomerulonephritis as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Tubulointerstitial Nephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Tubulointerstitial nephritis as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Polycystic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Polycystic kidney disease as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Ischemic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Ischemic kidney disease as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Nephrosclerosis/Hypertension as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Nephrosclerosis/hypertension as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Other Diagnosis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Other diagnosis as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Unknown Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Unknown primary cause of kidney failure as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Comorbidity in association with time to first peritonitis episode is presented. The Stoke grading system of cardiovascular comorbidity was used to reflect the comorbid burden. Comorbidity was graded 0 when absent, 1 when 1 or 2, and 2 when 3 or more conditions were present. The association of baseline variables (at PD start) or time-updated variables with time to first was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Ischemic Heart Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Ischemic heart disease (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Peripheral Vascular Disease or Stroke as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Peripheral vascular disease or stroke (yes vs. no) in association with time to first peritonitis episode is presented. Peripheral vascular disease or stroke includes distal aortic, renovascular, and cerebrovascular disease as well as symptomatic disease in these vascular territories e.g. cerebrovascular accident, claudication, amputation or significant stenosis \>50% on vascular imaging or Doppler ultrasound. The association of baseline variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Left Ventricular Dysfunction as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Left ventricular dysfunction (yes vs. no) in association with time to first peritonitis episode is presented. Left ventricular dysfunction includes clinical evidence of pulmonary oedema not attributable to errors in fluid balance or moderate to severe left ventricular dysfunction on echocardiography, or clinical signs of symptomatic moderate to severe heart failure. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Diabetes Mellitus as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Diabetes mellitus as comorbidity (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of System Collagen Vascular Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable System collagen vascular disease (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Other Significant Pathology as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Other significant pathology (yes vs. no) in association with time to first peritonitis episode is presented. Other significant pathology includes diseases like severe chronic obstructive airway disease, liver cirrhosis, psychotic illness, and severe osteoarthritis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Diabetes mellitus as comorbidity or main cause of kidney failure (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Previous Kidney Replacement Therapy in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Previous kidney replacement therapy (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Functional Status (Karnofsky Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Functional status (Karnofsky score) in association with time to first peritonitis episode in the whole study group is presented. Functional status was estimated using the Karnofsky Performance Scale with scores from 100 (Normal, no complains, no evidence of disease) to 0 (dead). 90 = Able to carry on normal activity, minor signs or symptoms of disease. 80 = Normal activity with effort, some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or do active work. 60 = Requires occasional assistance, but able to to care for most of her/his needs. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of the Social Factor Visual Impairment in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline variable Visual impairment (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of the Social Factor Impaired Hand Function in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline social factor Impaired hand function (yes vs. no) in association with time to first peritonitis episode is presented. The impairment of hand function was unspecified. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of the Social Factor Working Full or Part Time in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline social factor Working full or part time (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of the Social Factor Retired in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline social factor Retired (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of the Social Factor Living Alone in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline social factor Living alone (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of the Social Factor Need for Translation/Interpreter in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline social factor Working full or part time (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of the Social Factor Current Smoking in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline social factor Current smoking (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of the Biochemical Characteristic Serum Creatinine in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline biological characteristic Serum creatinine (micromol/L) in association with time to first peritonitis episode is presented. Serum creatinine was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of the Biochemical Characteristic Serum Urea in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline biological characteristic Serum urea (mmol/L) in association with time to first peritonitis episode is presented. Serum urea was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of the Biochemical Characteristic Serum Albumin in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline biological characteristic Serum albumin (g/L) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of the Biochemical Characteristic Serum Albumin (< 35 g/L vs. 35 g/L or More) in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline biological characteristic Serum albumin (\< 35 g/L vs. 35 g/L or more) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of the Biochemical Characteristic Haemoglobin in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of the baseline biological characteristic Serum haemoglobin (mmol/L) in association with time to first peritonitis episode is presented. Serum haemoglobin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of the Use of a Corticosteroid Drug in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The analysis of the use of a Corticosteroid drug (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Time-dependent univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on corticosteroid treatment at baseline is presented below.
Analysis of Cytotoxic Treatment in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Analysis of Cytotoxic treatment (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the time-dependent univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on cytotoxic treatment at baseline is presented below.
Analysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of Type of start of peritoneal dialysis in association with time to first peritonitis episode is presented. The type of start of peritoneal dialysis could be either planned or acute. The association of Type of start of peritoneal dialysis in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of The Use of Antibiotics Prior to PD Catheter Insertion in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The statistical analysis of The use of antibiotics prior to PD catheter insertion (yes vs. no) in association with time to first peritonitis episode is presented. Antibiotics prior to PD catheter insertion may be given to prevent infection. The association of The use of antibiotics prior to PD catheter insertion in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants who used antibiotics prior to PD catheter insertion is presented below.
Analysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.PD catheters could be either be straight or coiled. The statistical analysis of the type of PD catheter used (straight vs. coiled) in association with time to first peritonitis episode is presented. The association of the type of PD catheter used in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.PD modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the whole study group was studied. A participant either used CAPD (Continuous Ambulatory Peritoneal Dialysis) or APD (Automated Peritoneal Dialysis) but may change the PD modality during the study. This variable may vary with time and is thus time-dependent. The time-dependent data was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data was included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The c
Analysis of The Volume of Dialysis Fluid Used/24h in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The association of The Volume of Dialysis Fluid used/24h with the time to first peritonitis episode is analysed in the whole study group. The volume of dialysis fluid used per 24h can vary with time and is thus time-dependent. The dialysis fluid volume/24h used at PD start is reported below. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data were included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of Need of Help With Exit-site Care in Association With Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The exit site is the point where the PD catheter emerges from the skin of the abdomen. The number of participants who needed of help with exit-site care at PD start is reported below. The need of this help may vary with time. This variable is thus time-dependent. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The data were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis EpisodeParticipants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Analysis of the association of the Study group (retraining group vs. control group) with time to first peritonitis episode is presented. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Number of PD Bags Used/24h in Association With of Time to First Peritonitis Episode in the Whole Study Group.Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The association of the Number of PD bags used/24h and Time to First Peritonitis Episode was studied. The number of PD bags used/24h many vary with time, as this variable is thus time-dependent. Data from PD start is presented below. As described in Outcome measure 39, data was collected at each study visit. We recorded the number of bags connected to the PD catheter/24h in CAPD patients and in APD patients we recorded the number of bags connected to the tubing set/24h adding the daily number of bags connected to the PD catheter if additional manual daytime exchanges were used. The time-dependent data was included in a time-dependent univariable Cox regression to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.
Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study GroupParticipants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.The association of baseline variables (at PD start) was studied in the whole study group. Age was recorded at baseline. Data were collected at baseline except for medication, PD modality (CAPD/APD, continuous ambulatory PD/automatic PD), number of PD bags and volume of dialysis fluid used per day, and if help with exit-site care was needed. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.
Analysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study GroupParticipants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.Outcome data for the baseline variable Gender is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Countries

Sweden

Participant flow

Recruitment details

Recruitment started on January 18th, 2010 and ended on December 31st, 2014. The recruitment time was prolonged from planned two years to five years. Of the 713 initially included subjects, only 671 met the inclusion criteria. Of the 671 randomized subjects, 331 were assigned to the Control group and 340 to the Follow-up group.

Participants by arm

ArmCount
The Retraining Group
The intervention in the retraining group consisted of tests at the study visits of the patients´ theoretical and practical skills regarding peritoneal dialysis If the test goals were not passed, retraining was given until the goals were reached. The peritonitis rate in this group will be compared with that of the control group.
340
Control Group
Patients randomised to the control group were treated according to the routines of the clinic.
331
Total671

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath2729
Overall StudyInvestigator decision52
Overall StudyKidney function improved67
Overall StudyKidney transplantation10996
Overall StudyOther causes63
Overall StudyTransfer to assisted PD2418
Overall StudyTransfer to hemodialysis7090
Overall StudyWithdrawal by Subject260

Baseline characteristics

CharacteristicThe Retraining GroupTotalControl Group
Age 65 years or more164 Participants308 Participants144 Participants
Age, Continuous64 Years62 Years62 Years
Antibiotic prophylaxis before PD catheter insertion305 Participants610 Participants305 Participants
Body mass index26 Kg/m2
STANDARD_DEVIATION 4
26 Kg/m2
STANDARD_DEVIATION 4
26 Kg/m2
STANDARD_DEVIATION 4
Body weight77 Kg
STANDARD_DEVIATION 15
78 Kg
STANDARD_DEVIATION 15
79 Kg
STANDARD_DEVIATION 16
Comorbidity
Collagen vascular disease
20 participants30 participants10 participants
Comorbidity
Diabetes (comorbidity or main cause of kidney failure)
88 participants199 participants111 participants
Comorbidity
Ischemic heart disease
60 participants122 participants62 participants
Comorbidity
Left ventricular dysfunction
37 participants71 participants34 participants
Comorbidity
Other significant pathology
42 participants72 participants30 participants
Comorbidity
Peripheral vascular disease and stroke
39 participants66 participants27 participants
C-reactive protein3.0 g/L3.0 g/L3.0 g/L
Help needed with exit-site care79 Participants163 Participants84 Participants
Hemoglobin (at PD start)110 mmol/L
STANDARD_DEVIATION 14
111 mmol/L
STANDARD_DEVIATION 13
111 mmol/L
STANDARD_DEVIATION 12
Karnofsky performance scale for measurement of functional status90 Score90 Score90 Score
Medication
Corticosteroid drug
44 Participants87 Participants43 Participants
Medication
No steroid or other cytotoxic drug medication
269 Participants532 Participants263 Participants
Medication
Other cytotoxic drug
27 Participants52 Participants25 Participants
Participants from centers routinely using topical antibiotic cream on catheter exit site38 Participants72 Participants34 Participants
Participants from centers treating nasal carriers of S. aureus with nasal antibiotics73 Participants141 Participants68 Participants
PD catheter characteristics
Coiled
262 Participants517 Participants255 Participants
PD catheter characteristics
Straight
78 Participants154 Participants76 Participants
PD modality at PD start
APD
62 Participants131 Participants69 Participants
PD modality at PD start
CAPD
278 Participants540 Participants262 Participants
Primary cause of end-stage kidney disease
Diabetic nephropathy
63 Participants150 Participants87 Participants
Primary cause of end-stage kidney disease
Glomerulonephritis
87 Participants174 Participants87 Participants
Primary cause of end-stage kidney disease
Ischemic kidney kisease
1 Participants2 Participants1 Participants
Primary cause of end-stage kidney disease
Nephrosclerosis/Hypertension
78 Participants144 Participants66 Participants
Primary cause of end-stage kidney disease
Other diagnosis
38 Participants64 Participants26 Participants
Primary cause of end-stage kidney disease
Polycystic kidney disease
40 Participants69 Participants29 Participants
Primary cause of end-stage kidney disease
Tubulointerstitial nephritis
17 Participants34 Participants17 Participants
Primary cause of end-stage kidney disease
Unknown cause
16 Participants34 Participants18 Participants
Region of Enrollment
Denmark
32 participants59 participants27 participants
Region of Enrollment
Estonia
11 participants20 participants9 participants
Region of Enrollment
Finland
22 participants44 participants22 participants
Region of Enrollment
Latvia
25 participants50 participants25 participants
Region of Enrollment
Netherlands
25 participants51 participants26 participants
Region of Enrollment
Norway
30 participants56 participants26 participants
Region of Enrollment
Sweden
191 participants383 participants192 participants
Region of Enrollment
United Kingdom
4 participants8 participants4 participants
Serum albumin < 35 g/L (at PD start)169 Participants338 Participants169 Participants
Serum albumin (at PD start)34 g/L
STANDARD_DEVIATION 6
34 g/L
STANDARD_DEVIATION 6
34 g/L
STANDARD_DEVIATION 6
Serum creatinine (at PD start)640 Micromol/L
STANDARD_DEVIATION 234
645 Micromol/L
STANDARD_DEVIATION 222
650 Micromol/L
STANDARD_DEVIATION 208
Serum urea (at PD start)28 mmol/L
STANDARD_DEVIATION 9
28 mmol/L
STANDARD_DEVIATION 9
28 mmol/L
STANDARD_DEVIATION 9
Sex: Female, Male
Female
111 Participants225 Participants114 Participants
Sex: Female, Male
Male
229 Participants446 Participants217 Participants
Social factors
Current smoking
34 Participants73 Participants39 Participants
Social factors
Impaired hand function
23 Participants44 Participants21 Participants
Social factors
Living alone
91 Participants168 Participants77 Participants
Social factors
Need for translation/interpreter
9 Participants22 Participants13 Participants
Social factors
Retired
184 Participants353 Participants169 Participants
Social factors
Visual impairment with reading problems
17 Participants45 Participants28 Participants
Social factors
Working full or part time
103 Participants205 Participants102 Participants
Type of PD start
Acute
40 Participants93 Participants53 Participants
Type of PD start
Planned
300 Participants578 Participants278 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
27 / 34029 / 331
other
Total, other adverse events
0 / 3400 / 331
serious
Total, serious adverse events
0 / 3400 / 331

Outcome results

Primary

Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group

Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.

Population: A number of 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. Participant who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.

ArmMeasureValue (MEDIAN)
The Retraining GroupTime to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group381 Days to first peritonitis episode
Control GroupTime to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group368 Days to first peritonitis episode
Comparison: Time to the first peritonitis episode was analyzed as the cumulative time without peritonitis (peritonitis-free survival) using the Cox proportional hazards regression model from which unadjusted hazard ratios (HRs) were calculated. Actuarial survival curves showing proportions of of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log-rank follow-up was used to compare the two peritonitis-free survival curves.p-value: 0.5195% CI: [0.71, 1.19]Log Rank
Secondary

Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group

The incidence of a first peritonitis episode is expressed as the mean rate of a first peritonitis per patient year (event rate) with 95% confidence interval.

Time frame: The participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. The time in study was calculated for each participant

Population: 671 new patients with peritoneal dialysis, peritonitis-free, aged 18 year or more, and able to perform peritoneal dialysis without assistance were randomized to a control group or a follow-up group and followed up to 36 months after start of peritoneal dialysis. The time (patient-years) in the study to the first peritonitis episode was calculated for for each participant.

ArmMeasureValue (MEAN)
The Retraining GroupIncidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group0.29 Peritonitis events per patient-year
Control GroupIncidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group0.31 Peritonitis events per patient-year
p-value: 0.5195% CI: [0.7, 1.19]Generalized linear methods
Secondary

Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group

The incidence of peritonitis episodes is expressed as the mean rate of peritonitis per patient year (event rate) with 95% confidence interval.

Time frame: The participants were followed from 1 month after PD start (time of randomization) up to 36 months after start of peritoneal dialysis, The time (days) of participation in the study was calculated for each participant.

Population: 671 new patients with peritoneal dialysis, peritonitis-free, aged 18 year or more, and able to perform peritoneal dialysis without assistance were randomized to a control group or a follow-up group and followed up to 36 months after start of peritoneal dialysis.

ArmMeasureValue (MEAN)
The Retraining GroupIncidence of All Peritonitis Episodes in the Control Group and the Retraining Group0.36 Peritonitis event rate per patient year
Control GroupIncidence of All Peritonitis Episodes in the Control Group and the Retraining Group0.33 Peritonitis event rate per patient year
p-value: 0.5495% CI: [0.75, 1.16]Generalized linear methods
Other Pre-specified

Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group

The association of baseline variables (at PD start) was studied in the whole study group. Age was recorded at baseline. Data were collected at baseline except for medication, PD modality (CAPD/APD, continuous ambulatory PD/automatic PD), number of PD bags and volume of dialysis fluid used per day, and if help with exit-site care was needed. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEDIAN)
The Retraining GroupAnalysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group64 Age, years (See statistical analysis 1)
Control GroupAnalysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group62 Age, years (See statistical analysis 1)
The Whole Study GroupAnalysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group62 Age, years (See statistical analysis 1)
Comparison: The association of age and time to first peritonitis episode is analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.005295% CI: [1.04, 1.27]Regression, Cox
Comparison: Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode (see statistical analysis 1). Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.004195% CI: [1.05, 1.29]Regression, Cox
Other Pre-specified

Analysis of Body Mass Index in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for body mass index at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis episode in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEAN)Dispersion
The Retraining GroupAnalysis of Body Mass Index in Association With Time to First Peritonitis Episode in the Whole Study Group.26 Kg/m2Standard Deviation 4
Control GroupAnalysis of Body Mass Index in Association With Time to First Peritonitis Episode in the Whole Study Group.26 Kg/m2Standard Deviation 4
The Whole Study GroupAnalysis of Body Mass Index in Association With Time to First Peritonitis Episode in the Whole Study Group.26 Kg/m2Standard Deviation 4
Comparison: The association of Diabetic nephropathy as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.01295% CI: [1.04, 1.38]Regression, Cox
Other Pre-specified

Analysis of Body Weight in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for body weight at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEAN)Dispersion
The Retraining GroupAnalysis of Body Weight in Association With Time to First Peritonitis Episode in the Whole Study Group.77 KgStandard Deviation 15
Control GroupAnalysis of Body Weight in Association With Time to First Peritonitis Episode in the Whole Study Group.79 KgStandard Deviation 16
The Whole Study GroupAnalysis of Body Weight in Association With Time to First Peritonitis Episode in the Whole Study Group.78 KgStandard Deviation 15
Comparison: The association of body weight (HR per 10 kg) with time to first peritonitis episode was analysed by univariable Cox regression (Statistical analysis 1) and multivariable Cox regression (Statistical analysis 2)p-value: 0.006895% CI: [1.03, 1.21]Regression, Cox
Comparison: The association of body weight (HR per 10 kg) with time to first peritonitis episode was analysed by univariable Cox regression (Statistical analysis 1) and multivariable Cox regression (Statistical analysis 2)p-value: 0.0395% CI: [1.01, 1.19]Regression, Cox
Other Pre-specified

Analysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Comorbidity in association with time to first peritonitis episode is presented. The Stoke grading system of cardiovascular comorbidity was used to reflect the comorbid burden. Comorbidity was graded 0 when absent, 1 when 1 or 2, and 2 when 3 or more conditions were present. The association of baseline variables (at PD start) or time-updated variables with time to first was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke score 1-2 (1-2 comorbidities)128 Participants
The Retraining GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke score 0 (No comorbidity)193 Participants
The Retraining GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke Score > 2 (More than 2 comorbidities)19 Participants
Control GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke score 1-2 (1-2 comorbidities)117 Participants
Control GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke score 0 (No comorbidity)202 Participants
Control GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke Score > 2 (More than 2 comorbidities)12 Participants
The Whole Study GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke score 0 (No comorbidity)395 Participants
The Whole Study GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke Score > 2 (More than 2 comorbidities)31 Participants
The Whole Study GroupAnalysis of Comorbidity (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.Stoke score 1-2 (1-2 comorbidities)245 Participants
Comparison: The association of Comorbidity according to Stoke comorbidity score with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.2895% CI: [0.88, 1.53]Regression, Cox
Comparison: The association of Comorbidity according to Stoke comorbidity score with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.4495% CI: [0.68, 2.45]Regression, Cox
Other Pre-specified

Analysis of Cytotoxic Treatment in Association With Time to First Peritonitis Episode in the Whole Study Group.

Analysis of Cytotoxic treatment (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the time-dependent univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on cytotoxic treatment at baseline is presented below.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Cytotoxic Treatment in Association With Time to First Peritonitis Episode in the Whole Study Group.27 Participants
Control GroupAnalysis of Cytotoxic Treatment in Association With Time to First Peritonitis Episode in the Whole Study Group.25 Participants
The Whole Study GroupAnalysis of Cytotoxic Treatment in Association With Time to First Peritonitis Episode in the Whole Study Group.52 Participants
Comparison: The association of the time-dependent variable Cytotoxic treatment (yes vs. no) with time to first peritonitis episode was analysed by univariable time-dependent Cox regression.p-value: 0.695% CI: [0.7, 1.84]Regression, Cox
Other Pre-specified

Analysis of Diabetes Mellitus as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Diabetes mellitus as comorbidity (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Diabetes Mellitus as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.25 Participants
Control GroupAnalysis of Diabetes Mellitus as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.24 Participants
The Whole Study GroupAnalysis of Diabetes Mellitus as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.49 Participants
Comparison: The association of Diabetes Mellitus as Comorbidity (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.09995% CI: [0.93, 2.22]Regression, Cox
Other Pre-specified

Analysis of Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Diabetes mellitus as comorbidity or main cause of kidney failure (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.88 Participants
Control GroupAnalysis of Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.111 Participants
The Whole Study GroupAnalysis of Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.199 Participants
Comparison: The association of Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.6995% CI: [0.8, 1.4]Regression, Cox
Other Pre-specified

Analysis of Diabetic Nephropathy as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable Diabetic nephropathy as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Diabetic Nephropathy as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.63 Participants
Control GroupAnalysis of Diabetic Nephropathy as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.87 Participants
The Whole Study GroupAnalysis of Diabetic Nephropathy as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.150 Participants
Comparison: The association of Diabetic nephropathy as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.5695% CI: [0.66, 1.25]Regression, Cox
Other Pre-specified

Analysis of Functional Status (Karnofsky Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Functional status (Karnofsky score) in association with time to first peritonitis episode in the whole study group is presented. Functional status was estimated using the Karnofsky Performance Scale with scores from 100 (Normal, no complains, no evidence of disease) to 0 (dead). 90 = Able to carry on normal activity, minor signs or symptoms of disease. 80 = Normal activity with effort, some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or do active work. 60 = Requires occasional assistance, but able to to care for most of her/his needs. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEDIAN)
The Retraining GroupAnalysis of Functional Status (Karnofsky Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.90 Karnofsky score numbers
Control GroupAnalysis of Functional Status (Karnofsky Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.90 Karnofsky score numbers
The Whole Study GroupAnalysis of Functional Status (Karnofsky Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.90 Karnofsky score numbers
Comparison: The association of Functional status (Karnofsky score) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.695% CI: [0.98, 1.01]Regression, Cox
Comparison: The association of Functional status (Karnofsky score 80 - 90 vs. 100) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.4895% CI: [0.81, 1.57]Regression, Cox
Comparison: The association of Functional status (Karnofsky score \< 80 vs. 100) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.6395% CI: [0.69, 1.85]Regression, Cox
Other Pre-specified

Analysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study Group

Outcome data for the baseline variable Gender is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study GroupMale participants229 Participants
The Retraining GroupAnalysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study GroupFemale participants111 Participants
Control GroupAnalysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study GroupMale participants217 Participants
Control GroupAnalysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study GroupFemale participants114 Participants
The Whole Study GroupAnalysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study GroupMale participants446 Participants
The Whole Study GroupAnalysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study GroupFemale participants225 Participants
Comparison: The association of gender (male vs. female) and time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.1395% CI: [0.93, 1.66]Regression, Cox
Other Pre-specified

Analysis of Glomerulonephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable Glomerulonephritis as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Glomerulonephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.87 Participants
Control GroupAnalysis of Glomerulonephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.87 Participants
The Whole Study GroupAnalysis of Glomerulonephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.174 Participants
Comparison: The association of Glomerulonephritis as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.7495% CI: [0.78, 1.42]Regression, Cox
Other Pre-specified

Analysis of Ischemic Heart Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Ischemic heart disease (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Ischemic Heart Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.60 Participants
Control GroupAnalysis of Ischemic Heart Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.62 Participants
The Whole Study GroupAnalysis of Ischemic Heart Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.122 Participants
Comparison: The association of Ischemic Heart Disease as Comorbidity with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.0795% CI: [0.97, 1.87]Regression, Cox
Other Pre-specified

Analysis of Ischemic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable Ischemic kidney disease as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis episode in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Ischemic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.1 Participants
Control GroupAnalysis of Ischemic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.1 Participants
The Whole Study GroupAnalysis of Ischemic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.2 Participants
Comparison: The association of Ischemic kidney disease as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.5295% CI: [0.27, 13.68]Regression, Cox
Other Pre-specified

Analysis of Left Ventricular Dysfunction as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Left ventricular dysfunction (yes vs. no) in association with time to first peritonitis episode is presented. Left ventricular dysfunction includes clinical evidence of pulmonary oedema not attributable to errors in fluid balance or moderate to severe left ventricular dysfunction on echocardiography, or clinical signs of symptomatic moderate to severe heart failure. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Left Ventricular Dysfunction as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.37 Participants
Control GroupAnalysis of Left Ventricular Dysfunction as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.34 Participants
The Whole Study GroupAnalysis of Left Ventricular Dysfunction as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.71 Participants
Comparison: The association of Left ventricular dysfunction as comorbidity (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.5395% CI: [0.75, 1.77]Regression, Cox
Other Pre-specified

Analysis of Need of Help With Exit-site Care in Association With Time to First Peritonitis Episode in the Whole Study Group.

The exit site is the point where the PD catheter emerges from the skin of the abdomen. The number of participants who needed of help with exit-site care at PD start is reported below. The need of this help may vary with time. This variable is thus time-dependent. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The data were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Need of Help With Exit-site Care in Association With Time to First Peritonitis Episode in the Whole Study Group.84 Participants
Control GroupAnalysis of Need of Help With Exit-site Care in Association With Time to First Peritonitis Episode in the Whole Study Group.79 Participants
The Whole Study GroupAnalysis of Need of Help With Exit-site Care in Association With Time to First Peritonitis Episode in the Whole Study Group.163 Participants
Comparison: Data regarding the variable Help needed with exit-site care (yes vs. no) were included as time-varying covariates in a univariable time-dependent Cox regression in order to identify variables significantly associated with time to first peritonitis episode. The risk (hazard ratio) associated with the studied variable is reported..p-value: 0.7995% CI: [0.77, 1.41]Regression, Cox
Other Pre-specified

Analysis of Nephrosclerosis/Hypertension as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable Nephrosclerosis/hypertension as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Nephrosclerosis/Hypertension as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.78 Participants
Control GroupAnalysis of Nephrosclerosis/Hypertension as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.66 Participants
The Whole Study GroupAnalysis of Nephrosclerosis/Hypertension as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.144 Participants
Comparison: The association of Nephrosclerosis/Hypertension as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.1395% CI: [0.93, 1.71]Regression, Cox
Other Pre-specified

Analysis of Number of PD Bags Used/24h in Association With of Time to First Peritonitis Episode in the Whole Study Group.

The association of the Number of PD bags used/24h and Time to First Peritonitis Episode was studied. The number of PD bags used/24h many vary with time, as this variable is thus time-dependent. Data from PD start is presented below. As described in Outcome measure 39, data was collected at each study visit. We recorded the number of bags connected to the PD catheter/24h in CAPD patients and in APD patients we recorded the number of bags connected to the tubing set/24h adding the daily number of bags connected to the PD catheter if additional manual daytime exchanges were used. The time-dependent data was included in a time-dependent univariable Cox regression to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEDIAN)
The Retraining GroupAnalysis of Number of PD Bags Used/24h in Association With of Time to First Peritonitis Episode in the Whole Study Group.4 Number of PD bags/24h at PD start
Control GroupAnalysis of Number of PD Bags Used/24h in Association With of Time to First Peritonitis Episode in the Whole Study Group.4 Number of PD bags/24h at PD start
The Whole Study GroupAnalysis of Number of PD Bags Used/24h in Association With of Time to First Peritonitis Episode in the Whole Study Group.4. Number of PD bags/24h at PD start
Comparison: The data regarding the number of PD bags used/24h were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity was found. The risk (hazard ratio) associated with the studied variable is reported.p-value: <0.000195% CI: [1.17, 1.57]Regression, Cox
Comparison: Analysis of the association of Number of PD bags used per 24 hours with time to first peritonitis episode by multivariable time-dependent Cox regression. The multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with the studied variable is reported.p-value: <0.000595% CI: [1.13, 1.54]Regression, Cox
Other Pre-specified

Analysis of Other Diagnosis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable Other diagnosis as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Other Diagnosis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.38 Participants
Control GroupAnalysis of Other Diagnosis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.26 Participants
The Whole Study GroupAnalysis of Other Diagnosis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.64 Participants
Comparison: The association of Other Diagnosis as primary cause of kidney failure (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.7195% CI: [0.58, 1.45]Regression, Cox
Other Pre-specified

Analysis of Other Significant Pathology as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Other significant pathology (yes vs. no) in association with time to first peritonitis episode is presented. Other significant pathology includes diseases like severe chronic obstructive airway disease, liver cirrhosis, psychotic illness, and severe osteoarthritis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Other Significant Pathology as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.42 Participants
Control GroupAnalysis of Other Significant Pathology as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.30 Participants
The Whole Study GroupAnalysis of Other Significant Pathology as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.72 Participants
Comparison: The association of Other Significant Pathology as Comorbidity (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.7995% CI: [0.61, 1.46]Regression, Cox
Other Pre-specified

Analysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group.

PD modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the whole study group was studied. A participant either used CAPD (Continuous Ambulatory Peritoneal Dialysis) or APD (Automated Peritoneal Dialysis) but may change the PD modality during the study. This variable may vary with time and is thus time-dependent. The time-dependent data was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data was included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The c

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group.CAPD at PD start278 Participants
The Retraining GroupAnalysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group.APD at PD start62 Participants
Control GroupAnalysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group.CAPD at PD start262 Participants
Control GroupAnalysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group.APD at PD start69 Participants
The Whole Study GroupAnalysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group.CAPD at PD start540 Participants
The Whole Study GroupAnalysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group.APD at PD start131 Participants
Comparison: The PD modality (CAPD or APD) may vary with time and is thus time-dependent. Data were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.195% CI: [0.96, 1.66]Regression, Cox
Other Pre-specified

Analysis of Peripheral Vascular Disease or Stroke as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Peripheral vascular disease or stroke (yes vs. no) in association with time to first peritonitis episode is presented. Peripheral vascular disease or stroke includes distal aortic, renovascular, and cerebrovascular disease as well as symptomatic disease in these vascular territories e.g. cerebrovascular accident, claudication, amputation or significant stenosis \>50% on vascular imaging or Doppler ultrasound. The association of baseline variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Peripheral Vascular Disease or Stroke as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.39 Participants
Control GroupAnalysis of Peripheral Vascular Disease or Stroke as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.27 Participants
The Whole Study GroupAnalysis of Peripheral Vascular Disease or Stroke as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.66 Participants
Comparison: The association of Peripheral Vascular Disease or Stroke as Comorbidity with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.895% CI: [0.69, 1.63]Regression, Cox
Other Pre-specified

Analysis of Polycystic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable Polycystic kidney disease as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Polycystic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.40 Participants
Control GroupAnalysis of Polycystic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.29 Participants
The Whole Study GroupAnalysis of Polycystic Kidney Disease as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.69 Participants
Comparison: The association of Diabetic nephropathy as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.03895% CI: [0.33, 0.97]Regression, Cox
Other Pre-specified

Analysis of Previous Kidney Replacement Therapy in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Previous kidney replacement therapy (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Previous Kidney Replacement Therapy in Association With Time to First Peritonitis Episode in the Whole Study Group.68 Participants
Control GroupAnalysis of Previous Kidney Replacement Therapy in Association With Time to First Peritonitis Episode in the Whole Study Group.61 Participants
The Whole Study GroupAnalysis of Previous Kidney Replacement Therapy in Association With Time to First Peritonitis Episode in the Whole Study Group.129 Participants
Comparison: The association of Previous Kidney Replacement Therapy (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.8695% CI: [0.74, 1.42]Regression, Cox
Other Pre-specified

Analysis of System Collagen Vascular Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable System collagen vascular disease (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of System Collagen Vascular Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.20 Participants
Control GroupAnalysis of System Collagen Vascular Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.10 Participants
The Whole Study GroupAnalysis of System Collagen Vascular Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.30 Participants
Comparison: The association of System Collagen Vascular Disease as Comorbidity (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.2295% CI: [0.29, 1.32]Regression, Cox
Other Pre-specified

Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode

Analysis of the association of the Study group (retraining group vs. control group) with time to first peritonitis episode is presented. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode340 Participants
Control GroupAnalysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode331 Participants
The Whole Study GroupAnalysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode671 Participants
Comparison: Association ot the Retraining group vs. the Control group with time to first peritonitis episode by univariable Cox regressionp-value: 0.5295% CI: [0.71, 1.19]Regression, Cox
Other Pre-specified

Analysis of the Biochemical Characteristic Haemoglobin in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic Serum haemoglobin (mmol/L) in association with time to first peritonitis episode is presented. Serum haemoglobin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEAN)Dispersion
The Retraining GroupAnalysis of the Biochemical Characteristic Haemoglobin in Association With Time to First Peritonitis Episode in the Whole Study Group.110 mmol/LStandard Deviation 14
Control GroupAnalysis of the Biochemical Characteristic Haemoglobin in Association With Time to First Peritonitis Episode in the Whole Study Group.111 mmol/LStandard Deviation 12
The Whole Study GroupAnalysis of the Biochemical Characteristic Haemoglobin in Association With Time to First Peritonitis Episode in the Whole Study Group.111 mmol/LStandard Deviation 13
Comparison: The association of Haemoglobin (Hazard ratio per 10 g/L) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.6195% CI: [0.27, 2.17]Regression, Cox
Other Pre-specified

Analysis of the Biochemical Characteristic Serum Albumin (< 35 g/L vs. 35 g/L or More) in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic Serum albumin (\< 35 g/L vs. 35 g/L or more) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Biochemical Characteristic Serum Albumin (< 35 g/L vs. 35 g/L or More) in Association With Time to First Peritonitis Episode in the Whole Study Group.Serum albumin <35 g/L169 Participants
The Retraining GroupAnalysis of the Biochemical Characteristic Serum Albumin (< 35 g/L vs. 35 g/L or More) in Association With Time to First Peritonitis Episode in the Whole Study Group.Serum albumin 35 g/L or more171 Participants
Control GroupAnalysis of the Biochemical Characteristic Serum Albumin (< 35 g/L vs. 35 g/L or More) in Association With Time to First Peritonitis Episode in the Whole Study Group.Serum albumin <35 g/L169 Participants
Control GroupAnalysis of the Biochemical Characteristic Serum Albumin (< 35 g/L vs. 35 g/L or More) in Association With Time to First Peritonitis Episode in the Whole Study Group.Serum albumin 35 g/L or more162 Participants
The Whole Study GroupAnalysis of the Biochemical Characteristic Serum Albumin (< 35 g/L vs. 35 g/L or More) in Association With Time to First Peritonitis Episode in the Whole Study Group.Serum albumin <35 g/L338 Participants
The Whole Study GroupAnalysis of the Biochemical Characteristic Serum Albumin (< 35 g/L vs. 35 g/L or More) in Association With Time to First Peritonitis Episode in the Whole Study Group.Serum albumin 35 g/L or more333 Participants
Comparison: Analysis of the association of serum albumin (\<35 g/L vs. 35 g/l or more) with time to first peritonitis episode by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.01395% CI: [1.08, 1.82]Regression, Cox
Comparison: Analysis of the association of serum albumin (\<35 g/L vs. 35 g/L or more) with time to first peritonitis episode by multivariable Cox regression.p-value: 0.01595% CI: [1.06, 1.82]Regression, Cox
Other Pre-specified

Analysis of the Biochemical Characteristic Serum Albumin in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic Serum albumin (g/L) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEAN)Dispersion
The Retraining GroupAnalysis of the Biochemical Characteristic Serum Albumin in Association With Time to First Peritonitis Episode in the Whole Study Group.34 g/LStandard Deviation 6
Control GroupAnalysis of the Biochemical Characteristic Serum Albumin in Association With Time to First Peritonitis Episode in the Whole Study Group.34 g/LStandard Deviation 6
The Whole Study GroupAnalysis of the Biochemical Characteristic Serum Albumin in Association With Time to First Peritonitis Episode in the Whole Study Group.34 g/LStandard Deviation 6
Comparison: The association of Serum albumin (Hazard ratio per 5 g/L) with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.01995% CI: [0.79, 0.98]Regression, Cox
Other Pre-specified

Analysis of the Biochemical Characteristic Serum Creatinine in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic Serum creatinine (micromol/L) in association with time to first peritonitis episode is presented. Serum creatinine was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEAN)Dispersion
The Retraining GroupAnalysis of the Biochemical Characteristic Serum Creatinine in Association With Time to First Peritonitis Episode in the Whole Study Group.640 Micromol/LStandard Deviation 234
Control GroupAnalysis of the Biochemical Characteristic Serum Creatinine in Association With Time to First Peritonitis Episode in the Whole Study Group.650 Micromol/LStandard Deviation 208
The Whole Study GroupAnalysis of the Biochemical Characteristic Serum Creatinine in Association With Time to First Peritonitis Episode in the Whole Study Group.645 Micromol/LStandard Deviation 222
Comparison: The association of Serum creatinine (Hazard ratio per 100 micromol/L with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.1895% CI: [0.9, 1.02]Regression, Cox
Other Pre-specified

Analysis of the Biochemical Characteristic Serum Urea in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic Serum urea (mmol/L) in association with time to first peritonitis episode is presented. Serum urea was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEAN)Dispersion
The Retraining GroupAnalysis of the Biochemical Characteristic Serum Urea in Association With Time to First Peritonitis Episode in the Whole Study Group.28 mmol/LStandard Deviation 9
Control GroupAnalysis of the Biochemical Characteristic Serum Urea in Association With Time to First Peritonitis Episode in the Whole Study Group.28 mmol/LStandard Deviation 9
The Whole Study GroupAnalysis of the Biochemical Characteristic Serum Urea in Association With Time to First Peritonitis Episode in the Whole Study Group.28 mmol/LStandard Deviation 9
Comparison: The association of Serum urea (Hazard ratio per 5 mmol/l) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.3495% CI: [0.9, 1.04]Regression, Cox
Other Pre-specified

Analysis of the Social Factor Current Smoking in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor Current smoking (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Social Factor Current Smoking in Association With Time to First Peritonitis Episode in the Whole Study Group.34 Participants
Control GroupAnalysis of the Social Factor Current Smoking in Association With Time to First Peritonitis Episode in the Whole Study Group.39 Participants
The Whole Study GroupAnalysis of the Social Factor Current Smoking in Association With Time to First Peritonitis Episode in the Whole Study Group.73 Participants
Comparison: The association of Current smoking (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.695% CI: [0.75, 1.65]Regression, Cox
Other Pre-specified

Analysis of the Social Factor Impaired Hand Function in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor Impaired hand function (yes vs. no) in association with time to first peritonitis episode is presented. The impairment of hand function was unspecified. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Social Factor Impaired Hand Function in Association With Time to First Peritonitis Episode in the Whole Study Group.23 Participants
Control GroupAnalysis of the Social Factor Impaired Hand Function in Association With Time to First Peritonitis Episode in the Whole Study Group.21 Participants
The Whole Study GroupAnalysis of the Social Factor Impaired Hand Function in Association With Time to First Peritonitis Episode in the Whole Study Group.44 Participants
Comparison: The association of Impaired Hand Function (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.2995% CI: [0.8, 2.06]Regression, Cox
Other Pre-specified

Analysis of the Social Factor Living Alone in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor Living alone (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Social Factor Living Alone in Association With Time to First Peritonitis Episode in the Whole Study Group.91 Participants
Control GroupAnalysis of the Social Factor Living Alone in Association With Time to First Peritonitis Episode in the Whole Study Group.77 Participants
The Whole Study GroupAnalysis of the Social Factor Living Alone in Association With Time to First Peritonitis Episode in the Whole Study Group.168 Participants
Comparison: The association of Living alone (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.06495% CI: [0.98, 1.76]Regression, Cox
Other Pre-specified

Analysis of the Social Factor Need for Translation/Interpreter in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor Working full or part time (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Social Factor Need for Translation/Interpreter in Association With Time to First Peritonitis Episode in the Whole Study Group.9 Participants
Control GroupAnalysis of the Social Factor Need for Translation/Interpreter in Association With Time to First Peritonitis Episode in the Whole Study Group.13 Participants
The Whole Study GroupAnalysis of the Social Factor Need for Translation/Interpreter in Association With Time to First Peritonitis Episode in the Whole Study Group.22 Participants
Comparison: The association of Need for translation/interpreter with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.1495% CI: [0.18, 1.29]Regression, Cox
Other Pre-specified

Analysis of the Social Factor Retired in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor Retired (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Social Factor Retired in Association With Time to First Peritonitis Episode in the Whole Study Group.184 Participants
Control GroupAnalysis of the Social Factor Retired in Association With Time to First Peritonitis Episode in the Whole Study Group.169 Participants
The Whole Study GroupAnalysis of the Social Factor Retired in Association With Time to First Peritonitis Episode in the Whole Study Group.353 Participants
Comparison: The association of being retired (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.04195% CI: [1.01, 1.73]Regression, Cox
Other Pre-specified

Analysis of the Social Factor Visual Impairment in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable Visual impairment (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Social Factor Visual Impairment in Association With Time to First Peritonitis Episode in the Whole Study Group.17 Participants
Control GroupAnalysis of the Social Factor Visual Impairment in Association With Time to First Peritonitis Episode in the Whole Study Group.28 Participants
The Whole Study GroupAnalysis of the Social Factor Visual Impairment in Association With Time to First Peritonitis Episode in the Whole Study Group.45 Participants
Comparison: The association of the Social Factor Visual Impairment (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.7195% CI: [0.54, 1.53]Regression, Cox
Other Pre-specified

Analysis of the Social Factor Working Full or Part Time in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor Working full or part time (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Social Factor Working Full or Part Time in Association With Time to First Peritonitis Episode in the Whole Study Group.103 Participants
Control GroupAnalysis of the Social Factor Working Full or Part Time in Association With Time to First Peritonitis Episode in the Whole Study Group.102 Participants
The Whole Study GroupAnalysis of the Social Factor Working Full or Part Time in Association With Time to First Peritonitis Episode in the Whole Study Group.205 Participants
Comparison: The association of Working Full or Part Time (yes vs. no) with time to first peritonitis episode analysed by univariable Cox regression. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the procedure was found.p-value: 0.01695% CI: [0.5, 0.93]Regression, Cox
Other Pre-specified

Analysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group.

PD catheters could be either be straight or coiled. The statistical analysis of the type of PD catheter used (straight vs. coiled) in association with time to first peritonitis episode is presented. The association of the type of PD catheter used in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group.Straight PD catheter78 Participants
The Retraining GroupAnalysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group.Coiled PD catheter262 Participants
Control GroupAnalysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group.Straight PD catheter76 Participants
Control GroupAnalysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group.Coiled PD catheter255 Participants
The Whole Study GroupAnalysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group.Straight PD catheter154 Participants
The Whole Study GroupAnalysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group.Coiled PD catheter517 Participants
Comparison: The association of Type of PD catheter used (straight vs. coiled) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.6895% CI: [0.68, 1.28]Regression, Cox
Other Pre-specified

Analysis of the Use of a Corticosteroid Drug in Association With Time to First Peritonitis Episode in the Whole Study Group.

The analysis of the use of a Corticosteroid drug (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Time-dependent univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on corticosteroid treatment at baseline is presented below.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of the Use of a Corticosteroid Drug in Association With Time to First Peritonitis Episode in the Whole Study Group.44 Participants
Control GroupAnalysis of the Use of a Corticosteroid Drug in Association With Time to First Peritonitis Episode in the Whole Study Group.43 Participants
The Whole Study GroupAnalysis of the Use of a Corticosteroid Drug in Association With Time to First Peritonitis Episode in the Whole Study Group.87 Participants
Comparison: The association of the time-dependent variable Corticosteroid treatment (yes vs. no) with time to first peritonitis episode was analysed by time-dependent univariable Cox regression.p-value: 0.3395% CI: [0.54, 1.23]Regression, Cox
Other Pre-specified

Analysis of The Use of Antibiotics Prior to PD Catheter Insertion in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of The use of antibiotics prior to PD catheter insertion (yes vs. no) in association with time to first peritonitis episode is presented. Antibiotics prior to PD catheter insertion may be given to prevent infection. The association of The use of antibiotics prior to PD catheter insertion in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants who used antibiotics prior to PD catheter insertion is presented below.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis episode in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of The Use of Antibiotics Prior to PD Catheter Insertion in Association With Time to First Peritonitis Episode in the Whole Study Group.305 Participants
Control GroupAnalysis of The Use of Antibiotics Prior to PD Catheter Insertion in Association With Time to First Peritonitis Episode in the Whole Study Group.305 Participants
The Whole Study GroupAnalysis of The Use of Antibiotics Prior to PD Catheter Insertion in Association With Time to First Peritonitis Episode in the Whole Study Group.610 Participants
Comparison: The association of Antibiotics prior to PD catheter insertion (yes vs. no) with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.7795% CI: [0.66, 1.76]Regression, Cox
Other Pre-specified

Analysis of The Volume of Dialysis Fluid Used/24h in Association With Time to First Peritonitis Episode in the Whole Study Group.

The association of The Volume of Dialysis Fluid used/24h with the time to first peritonitis episode is analysed in the whole study group. The volume of dialysis fluid used per 24h can vary with time and is thus time-dependent. The dialysis fluid volume/24h used at PD start is reported below. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data were included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (MEDIAN)
The Retraining GroupAnalysis of The Volume of Dialysis Fluid Used/24h in Association With Time to First Peritonitis Episode in the Whole Study Group.8.0 Liter of PD fluid used/24h at PD start
Control GroupAnalysis of The Volume of Dialysis Fluid Used/24h in Association With Time to First Peritonitis Episode in the Whole Study Group.8.0 Liter of PD fluid used/24h at PD start
The Whole Study GroupAnalysis of The Volume of Dialysis Fluid Used/24h in Association With Time to First Peritonitis Episode in the Whole Study Group.8.0 Liter of PD fluid used/24h at PD start
Comparison: Data regarding Volume of dialysis fluid used/24h was included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity was found. The risk (hazard ratio) associated with the studied variable is reported.p-value: 0.1395% CI: [0.99, 1.08]Regression, Cox
Other Pre-specified

Analysis of Tubulointerstitial Nephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable Tubulointerstitial nephritis as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis episode in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Tubulointerstitial Nephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.17 Participants
Control GroupAnalysis of Tubulointerstitial Nephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.17 Participants
The Whole Study GroupAnalysis of Tubulointerstitial Nephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.34 Participants
Comparison: The association of Tubulointerstitial Nephritis as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.4295% CI: [0.73, 2.15]Regression, Cox
Other Pre-specified

Analysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of Type of start of peritoneal dialysis in association with time to first peritonitis episode is presented. The type of start of peritoneal dialysis could be either planned or acute. The association of Type of start of peritoneal dialysis in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group.Planned PD start300 Participants
The Retraining GroupAnalysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group.Acute PD start40 Participants
Control GroupAnalysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group.Planned PD start278 Participants
Control GroupAnalysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group.Acute PD start53 Participants
The Whole Study GroupAnalysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group.Planned PD start578 Participants
The Whole Study GroupAnalysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group.Acute PD start93 Participants
Comparison: The association of Type of PD start with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.7295% CI: [0.73, 1.57]Regression, Cox
Other Pre-specified

Analysis of Unknown Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable Unknown primary cause of kidney failure as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

Population: 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. We decided to perform the analysis of factors associated with time to first peritonitis in the two groups together, since the possibility to find such associations is likely to be greater in a larger than in a smaller group.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
The Retraining GroupAnalysis of Unknown Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.16 Participants
Control GroupAnalysis of Unknown Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.18 Participants
The Whole Study GroupAnalysis of Unknown Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.34 Participants
Comparison: The association of Unknown Primary Cause of Kidney Failure as primary cause of kidney failure with time to first peritonitis episode was analysed by univariable Cox regression.p-value: 0.8995% CI: [0.57, 1.91]Regression, Cox

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026