Dialysis Capd Infection, Kidney Failure, Chronic, Peritoneal Dialysis-associated Peritonitis
Conditions
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
Testing of the patients´ knowledge and retraining will be given if needed
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control 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, 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group | 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 | 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. |
| Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group | 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. | The incidence of peritonitis episodes is expressed as the mean rate of peritonitis per patient year (event rate) with 95% confidence interval. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 Episode | 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 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 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 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 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 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
| Arm | Count |
|---|---|
| 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 |
| Total | 671 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 27 | 29 |
| Overall Study | Investigator decision | 5 | 2 |
| Overall Study | Kidney function improved | 6 | 7 |
| Overall Study | Kidney transplantation | 109 | 96 |
| Overall Study | Other causes | 6 | 3 |
| Overall Study | Transfer to assisted PD | 24 | 18 |
| Overall Study | Transfer to hemodialysis | 70 | 90 |
| Overall Study | Withdrawal by Subject | 26 | 0 |
Baseline characteristics
| Characteristic | The Retraining Group | Total | Control Group |
|---|---|---|---|
| Age 65 years or more | 164 Participants | 308 Participants | 144 Participants |
| Age, Continuous | 64 Years | 62 Years | 62 Years |
| Antibiotic prophylaxis before PD catheter insertion | 305 Participants | 610 Participants | 305 Participants |
| Body mass index | 26 Kg/m2 STANDARD_DEVIATION 4 | 26 Kg/m2 STANDARD_DEVIATION 4 | 26 Kg/m2 STANDARD_DEVIATION 4 |
| Body weight | 77 Kg STANDARD_DEVIATION 15 | 78 Kg STANDARD_DEVIATION 15 | 79 Kg STANDARD_DEVIATION 16 |
| Comorbidity Collagen vascular disease | 20 participants | 30 participants | 10 participants |
| Comorbidity Diabetes (comorbidity or main cause of kidney failure) | 88 participants | 199 participants | 111 participants |
| Comorbidity Ischemic heart disease | 60 participants | 122 participants | 62 participants |
| Comorbidity Left ventricular dysfunction | 37 participants | 71 participants | 34 participants |
| Comorbidity Other significant pathology | 42 participants | 72 participants | 30 participants |
| Comorbidity Peripheral vascular disease and stroke | 39 participants | 66 participants | 27 participants |
| C-reactive protein | 3.0 g/L | 3.0 g/L | 3.0 g/L |
| Help needed with exit-site care | 79 Participants | 163 Participants | 84 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 status | 90 Score | 90 Score | 90 Score |
| Medication Corticosteroid drug | 44 Participants | 87 Participants | 43 Participants |
| Medication No steroid or other cytotoxic drug medication | 269 Participants | 532 Participants | 263 Participants |
| Medication Other cytotoxic drug | 27 Participants | 52 Participants | 25 Participants |
| Participants from centers routinely using topical antibiotic cream on catheter exit site | 38 Participants | 72 Participants | 34 Participants |
| Participants from centers treating nasal carriers of S. aureus with nasal antibiotics | 73 Participants | 141 Participants | 68 Participants |
| PD catheter characteristics Coiled | 262 Participants | 517 Participants | 255 Participants |
| PD catheter characteristics Straight | 78 Participants | 154 Participants | 76 Participants |
| PD modality at PD start APD | 62 Participants | 131 Participants | 69 Participants |
| PD modality at PD start CAPD | 278 Participants | 540 Participants | 262 Participants |
| Primary cause of end-stage kidney disease Diabetic nephropathy | 63 Participants | 150 Participants | 87 Participants |
| Primary cause of end-stage kidney disease Glomerulonephritis | 87 Participants | 174 Participants | 87 Participants |
| Primary cause of end-stage kidney disease Ischemic kidney kisease | 1 Participants | 2 Participants | 1 Participants |
| Primary cause of end-stage kidney disease Nephrosclerosis/Hypertension | 78 Participants | 144 Participants | 66 Participants |
| Primary cause of end-stage kidney disease Other diagnosis | 38 Participants | 64 Participants | 26 Participants |
| Primary cause of end-stage kidney disease Polycystic kidney disease | 40 Participants | 69 Participants | 29 Participants |
| Primary cause of end-stage kidney disease Tubulointerstitial nephritis | 17 Participants | 34 Participants | 17 Participants |
| Primary cause of end-stage kidney disease Unknown cause | 16 Participants | 34 Participants | 18 Participants |
| Region of Enrollment Denmark | 32 participants | 59 participants | 27 participants |
| Region of Enrollment Estonia | 11 participants | 20 participants | 9 participants |
| Region of Enrollment Finland | 22 participants | 44 participants | 22 participants |
| Region of Enrollment Latvia | 25 participants | 50 participants | 25 participants |
| Region of Enrollment Netherlands | 25 participants | 51 participants | 26 participants |
| Region of Enrollment Norway | 30 participants | 56 participants | 26 participants |
| Region of Enrollment Sweden | 191 participants | 383 participants | 192 participants |
| Region of Enrollment United Kingdom | 4 participants | 8 participants | 4 participants |
| Serum albumin < 35 g/L (at PD start) | 169 Participants | 338 Participants | 169 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 Participants | 225 Participants | 114 Participants |
| Sex: Female, Male Male | 229 Participants | 446 Participants | 217 Participants |
| Social factors Current smoking | 34 Participants | 73 Participants | 39 Participants |
| Social factors Impaired hand function | 23 Participants | 44 Participants | 21 Participants |
| Social factors Living alone | 91 Participants | 168 Participants | 77 Participants |
| Social factors Need for translation/interpreter | 9 Participants | 22 Participants | 13 Participants |
| Social factors Retired | 184 Participants | 353 Participants | 169 Participants |
| Social factors Visual impairment with reading problems | 17 Participants | 45 Participants | 28 Participants |
| Social factors Working full or part time | 103 Participants | 205 Participants | 102 Participants |
| Type of PD start Acute | 40 Participants | 93 Participants | 53 Participants |
| Type of PD start Planned | 300 Participants | 578 Participants | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 27 / 340 | 29 / 331 |
| other Total, other adverse events | 0 / 340 | 0 / 331 |
| serious Total, serious adverse events | 0 / 340 | 0 / 331 |
Outcome results
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Retraining Group | Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group | 381 Days to first peritonitis episode |
| Control Group | Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group | 368 Days to first peritonitis episode |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| The Retraining Group | Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group | 0.29 Peritonitis events per patient-year |
| Control Group | Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group | 0.31 Peritonitis events per patient-year |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| The Retraining Group | Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group | 0.36 Peritonitis event rate per patient year |
| Control Group | Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group | 0.33 Peritonitis event rate per patient year |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Retraining Group | Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group | 64 Age, years (See statistical analysis 1) |
| Control Group | Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group | 62 Age, years (See statistical analysis 1) |
| The Whole Study Group | Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group | 62 Age, years (See statistical analysis 1) |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Retraining Group | Analysis of Body Mass Index in Association With Time to First Peritonitis Episode in the Whole Study Group. | 26 Kg/m2 | Standard Deviation 4 |
| Control Group | Analysis of Body Mass Index in Association With Time to First Peritonitis Episode in the Whole Study Group. | 26 Kg/m2 | Standard Deviation 4 |
| The Whole Study Group | Analysis of Body Mass Index in Association With Time to First Peritonitis Episode in the Whole Study Group. | 26 Kg/m2 | Standard Deviation 4 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Retraining Group | Analysis of Body Weight in Association With Time to First Peritonitis Episode in the Whole Study Group. | 77 Kg | Standard Deviation 15 |
| Control Group | Analysis of Body Weight in Association With Time to First Peritonitis Episode in the Whole Study Group. | 79 Kg | Standard Deviation 16 |
| The Whole Study Group | Analysis of Body Weight in Association With Time to First Peritonitis Episode in the Whole Study Group. | 78 Kg | Standard Deviation 15 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Cytotoxic Treatment in Association With Time to First Peritonitis Episode in the Whole Study Group. | 27 Participants |
| Control Group | Analysis of Cytotoxic Treatment in Association With Time to First Peritonitis Episode in the Whole Study Group. | 25 Participants |
| The Whole Study Group | Analysis of Cytotoxic Treatment in Association With Time to First Peritonitis Episode in the Whole Study Group. | 52 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Diabetes Mellitus as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 25 Participants |
| Control Group | Analysis of Diabetes Mellitus as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 24 Participants |
| The Whole Study Group | Analysis of Diabetes Mellitus as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 49 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | 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. | 88 Participants |
| Control Group | 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. | 111 Participants |
| The Whole Study Group | 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. | 199 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis of Diabetic Nephropathy as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group. | 150 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Retraining Group | Analysis of Functional Status (Karnofsky Score) in Association With Time to First Peritonitis Episode in the Whole Study Group. | 90 Karnofsky score numbers |
| Control Group | Analysis 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 Group | Analysis of Functional Status (Karnofsky Score) in Association With Time to First Peritonitis Episode in the Whole Study Group. | 90 Karnofsky score numbers |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Retraining Group | Analysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study Group | Male participants | 229 Participants |
| The Retraining Group | Analysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study Group | Female participants | 111 Participants |
| Control Group | Analysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study Group | Male participants | 217 Participants |
| Control Group | Analysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study Group | Female participants | 114 Participants |
| The Whole Study Group | Analysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study Group | Male participants | 446 Participants |
| The Whole Study Group | Analysis of Gender in Association With Time to First Peritonitis Episode in the Whole Study Group | Female participants | 225 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Glomerulonephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group. | 87 Participants |
| Control Group | Analysis 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 Group | Analysis of Glomerulonephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group. | 174 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Ischemic Heart Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 60 Participants |
| Control Group | Analysis of Ischemic Heart Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 62 Participants |
| The Whole Study Group | Analysis of Ischemic Heart Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 122 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Left Ventricular Dysfunction as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 37 Participants |
| Control Group | Analysis of Left Ventricular Dysfunction as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 34 Participants |
| The Whole Study Group | Analysis of Left Ventricular Dysfunction as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 71 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Need of Help With Exit-site Care in Association With Time to First Peritonitis Episode in the Whole Study Group. | 84 Participants |
| Control Group | Analysis 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 Group | Analysis of Need of Help With Exit-site Care in Association With Time to First Peritonitis Episode in the Whole Study Group. | 163 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis of Nephrosclerosis/Hypertension as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group. | 144 Participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis of Other Diagnosis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group. | 64 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Other Significant Pathology as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 42 Participants |
| Control Group | Analysis of Other Significant Pathology as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 30 Participants |
| The Whole Study Group | Analysis of Other Significant Pathology as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 72 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Retraining Group | Analysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group. | CAPD at PD start | 278 Participants |
| The Retraining Group | Analysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group. | APD at PD start | 62 Participants |
| Control Group | Analysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group. | CAPD at PD start | 262 Participants |
| Control Group | Analysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group. | APD at PD start | 69 Participants |
| The Whole Study Group | Analysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group. | CAPD at PD start | 540 Participants |
| The Whole Study Group | Analysis of PD Modality (CAPD/APD) in Association With Time to First Peritonitis Episode in the Whole Study Group. | APD at PD start | 131 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Peripheral Vascular Disease or Stroke as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 39 Participants |
| Control Group | Analysis 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 Group | Analysis of Peripheral Vascular Disease or Stroke as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 66 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Previous Kidney Replacement Therapy in Association With Time to First Peritonitis Episode in the Whole Study Group. | 68 Participants |
| Control Group | Analysis of Previous Kidney Replacement Therapy in Association With Time to First Peritonitis Episode in the Whole Study Group. | 61 Participants |
| The Whole Study Group | Analysis of Previous Kidney Replacement Therapy in Association With Time to First Peritonitis Episode in the Whole Study Group. | 129 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of System Collagen Vascular Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 20 Participants |
| Control Group | Analysis 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 Group | Analysis of System Collagen Vascular Disease as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group. | 30 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode | 340 Participants |
| Control Group | Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode | 331 Participants |
| The Whole Study Group | Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode | 671 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Retraining Group | Analysis of the Biochemical Characteristic Haemoglobin in Association With Time to First Peritonitis Episode in the Whole Study Group. | 110 mmol/L | Standard Deviation 14 |
| Control Group | Analysis of the Biochemical Characteristic Haemoglobin in Association With Time to First Peritonitis Episode in the Whole Study Group. | 111 mmol/L | Standard Deviation 12 |
| The Whole Study Group | Analysis of the Biochemical Characteristic Haemoglobin in Association With Time to First Peritonitis Episode in the Whole Study Group. | 111 mmol/L | Standard Deviation 13 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Retraining Group | 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. | Serum albumin <35 g/L | 169 Participants |
| The Retraining Group | 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. | Serum albumin 35 g/L or more | 171 Participants |
| Control Group | 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. | Serum albumin <35 g/L | 169 Participants |
| Control Group | 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. | Serum albumin 35 g/L or more | 162 Participants |
| The Whole Study Group | 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. | Serum albumin <35 g/L | 338 Participants |
| The Whole Study Group | 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. | Serum albumin 35 g/L or more | 333 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Retraining Group | Analysis of the Biochemical Characteristic Serum Albumin in Association With Time to First Peritonitis Episode in the Whole Study Group. | 34 g/L | Standard Deviation 6 |
| Control Group | Analysis of the Biochemical Characteristic Serum Albumin in Association With Time to First Peritonitis Episode in the Whole Study Group. | 34 g/L | Standard Deviation 6 |
| The Whole Study Group | Analysis of the Biochemical Characteristic Serum Albumin in Association With Time to First Peritonitis Episode in the Whole Study Group. | 34 g/L | Standard Deviation 6 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Retraining Group | Analysis of the Biochemical Characteristic Serum Creatinine in Association With Time to First Peritonitis Episode in the Whole Study Group. | 640 Micromol/L | Standard Deviation 234 |
| Control Group | Analysis of the Biochemical Characteristic Serum Creatinine in Association With Time to First Peritonitis Episode in the Whole Study Group. | 650 Micromol/L | Standard Deviation 208 |
| The Whole Study Group | Analysis of the Biochemical Characteristic Serum Creatinine in Association With Time to First Peritonitis Episode in the Whole Study Group. | 645 Micromol/L | Standard Deviation 222 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The Retraining Group | Analysis of the Biochemical Characteristic Serum Urea in Association With Time to First Peritonitis Episode in the Whole Study Group. | 28 mmol/L | Standard Deviation 9 |
| Control Group | Analysis of the Biochemical Characteristic Serum Urea in Association With Time to First Peritonitis Episode in the Whole Study Group. | 28 mmol/L | Standard Deviation 9 |
| The Whole Study Group | Analysis of the Biochemical Characteristic Serum Urea in Association With Time to First Peritonitis Episode in the Whole Study Group. | 28 mmol/L | Standard Deviation 9 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of the Social Factor Current Smoking in Association With Time to First Peritonitis Episode in the Whole Study Group. | 34 Participants |
| Control Group | Analysis of the Social Factor Current Smoking in Association With Time to First Peritonitis Episode in the Whole Study Group. | 39 Participants |
| The Whole Study Group | Analysis of the Social Factor Current Smoking in Association With Time to First Peritonitis Episode in the Whole Study Group. | 73 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of the Social Factor Impaired Hand Function in Association With Time to First Peritonitis Episode in the Whole Study Group. | 23 Participants |
| Control Group | Analysis 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 Group | Analysis of the Social Factor Impaired Hand Function in Association With Time to First Peritonitis Episode in the Whole Study Group. | 44 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of the Social Factor Living Alone in Association With Time to First Peritonitis Episode in the Whole Study Group. | 91 Participants |
| Control Group | Analysis of the Social Factor Living Alone in Association With Time to First Peritonitis Episode in the Whole Study Group. | 77 Participants |
| The Whole Study Group | Analysis of the Social Factor Living Alone in Association With Time to First Peritonitis Episode in the Whole Study Group. | 168 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of the Social Factor Need for Translation/Interpreter in Association With Time to First Peritonitis Episode in the Whole Study Group. | 9 Participants |
| Control Group | Analysis 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 Group | Analysis of the Social Factor Need for Translation/Interpreter in Association With Time to First Peritonitis Episode in the Whole Study Group. | 22 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of the Social Factor Retired in Association With Time to First Peritonitis Episode in the Whole Study Group. | 184 Participants |
| Control Group | Analysis of the Social Factor Retired in Association With Time to First Peritonitis Episode in the Whole Study Group. | 169 Participants |
| The Whole Study Group | Analysis of the Social Factor Retired in Association With Time to First Peritonitis Episode in the Whole Study Group. | 353 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of the Social Factor Visual Impairment in Association With Time to First Peritonitis Episode in the Whole Study Group. | 17 Participants |
| Control Group | Analysis of the Social Factor Visual Impairment in Association With Time to First Peritonitis Episode in the Whole Study Group. | 28 Participants |
| The Whole Study Group | Analysis of the Social Factor Visual Impairment in Association With Time to First Peritonitis Episode in the Whole Study Group. | 45 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis of the Social Factor Working Full or Part Time in Association With Time to First Peritonitis Episode in the Whole Study Group. | 205 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Retraining Group | Analysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group. | Straight PD catheter | 78 Participants |
| The Retraining Group | Analysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group. | Coiled PD catheter | 262 Participants |
| Control Group | Analysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group. | Straight PD catheter | 76 Participants |
| Control Group | Analysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group. | Coiled PD catheter | 255 Participants |
| The Whole Study Group | Analysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group. | Straight PD catheter | 154 Participants |
| The Whole Study Group | Analysis of the Type of PD Catheter Used in Association With Time to First Peritonitis Episode in the Whole Study Group. | Coiled PD catheter | 517 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of the Use of a Corticosteroid Drug in Association With Time to First Peritonitis Episode in the Whole Study Group. | 44 Participants |
| Control Group | Analysis 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 Group | Analysis of the Use of a Corticosteroid Drug in Association With Time to First Peritonitis Episode in the Whole Study Group. | 87 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis 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 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis 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 Group | Analysis 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 Group | Analysis of Tubulointerstitial Nephritis as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group. | 34 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The Retraining Group | Analysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group. | Planned PD start | 300 Participants |
| The Retraining Group | Analysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group. | Acute PD start | 40 Participants |
| Control Group | Analysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group. | Planned PD start | 278 Participants |
| Control Group | Analysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group. | Acute PD start | 53 Participants |
| The Whole Study Group | Analysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group. | Planned PD start | 578 Participants |
| The Whole Study Group | Analysis of Type of Start of Peritoneal Dialysis in Association With Time to First Peritonitis Episode in the Whole Study Group. | Acute PD start | 93 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Retraining Group | Analysis of Unknown Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group. | 16 Participants |
| Control Group | Analysis 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 Group | Analysis of Unknown Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group. | 34 Participants |