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Treatment of Peritonitis in Automated Peritoneal Dialysis

Randomized Multicentric Clinical Trial, Efficcacy of the Treatment Application on Peritonitis in Automated Peritoneal Dialysis (APD); Comparision Between APD Versus Ambulatory Dialysis.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04077996
Enrollment
64
Registered
2019-09-04
Start date
2019-07-01
Completion date
2022-08-30
Last updated
2025-03-26

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

Conditions

Secondary Peritonitis

Keywords

PERITONITIS, AUTOMATED PERITONEAL DIALYSIS, TREATMENT OF PERITONITIS

Brief summary

The main infectious complication of peritoneal dialysis (PD) is bacterial peritonitis, which increases morbidity, mortality and conversion to hemodialysis. In Mexico, 485 patients per million people undergo PD. The Mexican Institute of Social Security (IMSS) reported 55,101 patients with kidney failure, 59% on PD. Automated PD (APD) has contributed by reducing peritonitis. The treatment of peritonitis in APD is carried out by changing to continuous ambulatory peritoneal dialysis (CAPD) or by adding a CAPD/day replacement, increasing costs and delaying treatment. OBJECTIVE: To compare the efficacy of peritonitis antibiotic treatment applied in a DPA bag versus applied in a CAPD/day replacement plus APD in IMSS beneficiaries. MATERIAL AND METHODS: A non-inferiority, multicenter clinical trial was carried out with patients\> 18 years of age in APD with peritonitis. Group 1 (g1) receives antibiotics in DPA bags, group 2 (g2) receives antibiotics in a CAPD / day exchange plus APD. The antibiotics applied were ceftazidime 1500 mg / day 14 days and vancomycin 20 mg / kg every 3 days, 5 doses adjusted according to culture, followed by cytology every 48 hours until clinical resolution. Considering resolved peritonitis when symptoms disappeared and white blood cells \<100 cells / mm3 were obtained in cytology. The Research and Ethics Committee approved the study. Relative risk (RR), relative risk reduction (RRR) were calculated. The Chi squared test, Student's t test, non-inferiority analysis was calculated considering p \<0.05 significant, SPSS 24 and Epi Info were used.

Detailed description

GENERAL DESCRIPTION OF THE STUDY. PROCEDURES: Patients with peritonitis (clinical, cytological sample with leukocytes \>100/μL, and \>50% Polymorphonuclear, taken from a dialysis exchange with 2 to 4 h of stay in the cavity, gram positive or positive culture of dialysis fluid) in Automated peritoneal dialysis of the general hospitals of the Mexican Institute zone Social Security No. 1, 10 and subzone 4 in the state of Colima. Two groups each of 32 patients were forming. Both created treatment groups received antibiotic management based on a double antibiotic scheme with Vancomycin and Ceftazidime via intraperitoneal (IP), the difference was for the treatment group (group 1) the application of the antibiotic through the 6L bags in APD through the cycler machine versus for the control group (group 2) the addition of a manual exchange (CAPD) of 6 hours of stay in extra cavity during the day for the application of the antibiotic plus the Usual APD at night, the management of peritonitis in each group was established according to the following way: * Group 1: IP antibiotic treatment applied inside DPA bags. Applied Vancomycin-based antibiotic 20 mg/kg every 72 hours (3 days) applied to bags of DPA (50% in each bag of the total dose) in night exchange every 3 days completing 5 doses, and Ceftazidime 1500mg applied in bags of DPA (50% in each bag of the total dose) each day for 14 days. * Group 2: IP antibiotic treatment applied to one manual exchange (CAPD) per day, with a stay of 6 hours plus usual DPA programmed at night. The dose administered was Vancomycin 20 mg/kg every 72 hours (3 days) completing 5 dose, and Ceftazidime 1500 mg/day in a manual exchange with a stay of 6 hours for 14 days plus the usual prescribed DPA at night. * Both groups received training and reviewed the correct application of the antibiotic by the nursing staff of the peritoneal dialysis service during hospitalization or at appointments in the peritoneal dialysis program. * The researchers and staff of the dialysis program maintained a follow-up of the cases during their stay in hospital, through home visits, phone call and check-up medical appointment. Patients and relatives were informed in detail about the research project companions mentioning the objectives, risks and benefits of this, their Authorization for inclusion in the study by signing an endorsed informed consent by the national ethics and research committee of the IMSS. Through direct interview and review of the medical record, general and demographic data, data on associated pathologies, comorbidities, time in management with peritoneal dialysis, time of APD management, number of peritoneal catheters placed, APD prescription, diuresis residual, dose of erythropoietin, onset of the clinical picture of peritonitis, as well as the characteristics of the initial frame, time elapsed from the beginning of the frame to the performance of cytology. Possible triggering causes of the symptoms of peritonitis, the peritoneal dialysis technique was verified, other probable sites of infection and close contact was maintained with the medical team in charge of managing the cases hospitalized. After the diagnosis or suspicion of the case of peritonitis, a culture of fluid was taken from dialysis (LD) without antibiotics, and was reviewed at 48 and 72 h and 5 days after starting the treatment, collecting the report with corresponding antibiogram. Cultivation was the basis for making the decision to change the antibiotic according to the sensitivity and reported resistance. All patients underwent fluid cytology controls. of PD every 48 hours in hospitalization or by scheduled appointment to PD programs from each hospital. The cytological ones were obtained from a manual exchange (CAPD) with 2 to 4 hours of stay in the cavity without antibiotics to determine the evolution of the symptoms of peritonitis. Through the cytological results and the clinical characteristics, the resolution of the peritonitis. At the beginning and at the end of the peritonitis, biochemical studies were performed: complete blood count (CBC), blood chemistry (QS), serum electrolytes (Na, K, Cl), general urinalysis (EGO) in case of residual urine, culture of site discharge catheter insertion in case of presenting and culture of peritoneal dialysis fluid. Recorded the clinical features of peritonitis (cloudy PD fluid, abdominal pain, nause).

Interventions

DEVICEPeritonitis treatment placed in APD

Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.

DEVICEPeritonitis treatment with one exchange in CAPD

Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.

Sponsors

Instituto Mexicano del Seguro Social
CollaboratorOTHER_GOV
Universidad de Colima
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

the outcomes assessor will mask to do statistical analisis

Intervention model description

Patients will be randomly through table of random numbers, and divided to form two treatment groups with 32 patients per group. One of which will be a APD and the other a CAPD + APD. The initial antibiotic scheme will be applied to both groups continuously based on: ceftazidime (1500-2000mg/day) and vancomycin (20mg/kg every 3 days) according to current management guidelines;

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* \> 18 years in Automated Peritoneal Dialysis. * Patients in the Hospital General 1, 10 and sub-zone 4 of Colima. * Patients with diagnosis of peritonitis (abdominal pain, fever, vomiting, nausea, turbid fluid, cytologic with leukocytes \>100 cells/mm3, polymorphonuclear \>50%). * Functional catheter. * Signed informed consent of acceptance to participate in the study.

Exclusion criteria

* Patients allergic to vancomicyn. * Patients allergic to ceftazidime. * Patients with Intestinal perforation. * Patients with abdominal cavity classified as unfit to PD.

Design outcomes

Primary

MeasureTime frameDescription
Peritonitis Resolved14 to 21 daysWe consider the problem resolved when symptoms (nausea, vomiting, abdominal pain, fever, turbid fluid) have disappeared and negative cytology has been obtained (leukocytes \<100 cells/mm3)

Secondary

MeasureTime frameDescription
Death of Patient21 daysTotal number and percentage of patients

Countries

Mexico

Participant flow

Recruitment details

71 patients were diagnosed with peritonitis. 7 patients were excluded because, 5 patients did not meet criteria and 2 voluntary abandonment

Participants by arm

ArmCount
Peritonitis Treatment With One Exchange in CAPD
32 patients in this group will receive peritonitis treatment with one exchange on Continuous Ambulatory Peritoneal Dialysis per day. The antibiotic scheme will be with ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days) according to current management guidelines; adjusting the management according to the result of the culture, completing the antibiotic scheme for 14 to 21 days. Peritonitis treatment with one exchange in CAPD: Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.
32
Peritonitis Treatment Placed in APD
32 patiets in this group will receive peritonitis treatment placed in Automated Peritoneal Dialysis, The antibiotic scheme will be with ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days); adjusting the management according to the result of the culture, completing the antibiotic scheme for 14 to 21 days. Peritonitis treatment placed in APD: Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.
32
Total64

Baseline characteristics

CharacteristicPeritonitis Treatment Placed in APDPeritonitis Treatment With One Exchange in CAPDTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants5 Participants8 Participants
Age, Categorical
Between 18 and 65 years
29 Participants27 Participants56 Participants
Age, Continuous47.4 years
STANDARD_DEVIATION 4.6
51.5 years
STANDARD_DEVIATION 16.9
49.42 years
STANDARD_DEVIATION 72.64
Alcohol consumption (yes)
Alcohol consumption
22 Participants24 Participants46 Participants
Alcohol consumption (yes)
No Alcohol consumption
10 Participants8 Participants18 Participants
Anemia (yes)29 Participants29 Participants58 Participants
APD modality
CCPD, continuous cycling peritoneal dialysi
29 Participants30 Participants59 Participants
APD modality
INPD, intermittent nocturnal peritoneal dialysis
3 Participants2 Participants5 Participants
APD per day, duration (hours)9.5 Hours
STANDARD_DEVIATION 0.6
9.6 Hours
STANDARD_DEVIATION 0.5
9.55 Hours
STANDARD_DEVIATION 0.56
Arterial hypertension (yes)31 Participants31 Participants62 Participants
Body Mass Index26.6 kg/m^2
STANDARD_DEVIATION 4.9
27.9 kg/m^2
STANDARD_DEVIATION 6
27.23 kg/m^2
STANDARD_DEVIATION 5.49
Exchanges per day (number)5.2 Exchanges per day (number)
STANDARD_DEVIATION 0.8
5.2 Exchanges per day (number)
STANDARD_DEVIATION 0.9
5.2 Exchanges per day (number)
STANDARD_DEVIATION 0.87
Hypercholesterolemia (yes16 Participants16 Participants32 Participants
Hypertriglyceridemia (yes19 Participants15 Participants34 Participants
Hyperuricemia (yes)9 Participants8 Participants17 Participants
Previous peritonitis episode (yes)20 Participants17 Participants37 Participants
Race/Ethnicity, Customized
spanish race
32 Participants32 Participants64 Participants
Region of Enrollment
Mexico
32 participants32 participants64 participants
Sex: Female, Male
Female
10 Participants7 Participants17 Participants
Sex: Female, Male
Male
22 Participants25 Participants47 Participants
Tobacco use (yes)18 Participants20 Participants38 Participants
Type 2 diabetes mellitus (yes)15 Participants21 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 322 / 32
other
Total, other adverse events
0 / 320 / 32
serious
Total, serious adverse events
0 / 320 / 32

Outcome results

Primary

Peritonitis Resolved

We consider the problem resolved when symptoms (nausea, vomiting, abdominal pain, fever, turbid fluid) have disappeared and negative cytology has been obtained (leukocytes \<100 cells/mm3)

Time frame: 14 to 21 days

Population: non-inferiority and the intent-to-treat

ArmMeasureValue (NUMBER)
Peritonitis Treatment With ANTIBIOTIC in a Exchange in CAPD + Usual APDPeritonitis Resolved26 participants
Peritonitis Treatment Placed in APDPeritonitis Resolved29 participants
Comparison: Summary statistics were computed, and a significance level (α) of 5% has been established.p-value: <0.0595% CI: [0.91, 1.3]Chi-squared, Corrected
p-value: <0.05Fisher Exact
Secondary

Death of Patient

Total number and percentage of patients

Time frame: 21 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Peritonitis Treatment With ANTIBIOTIC in a Exchange in CAPD + Usual APDDeath of Patient2 Participants
Peritonitis Treatment Placed in APDDeath of Patient2 Participants
p-value: <0.051% CI: [0.14, 6.6]Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026