CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
Peritonitis treatment placed in APD +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04077996
NCT04077996N/ACompleted

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

Universidad de Colima·interventional·Posted Sep 4, 2019·Updated Mar 26, 2025

In Brief

A clinical study evaluating Peritonitis treatment placed in APD and Peritonitis treatment with one exchange in CAPD for Secondary Peritonitis. Completed, enrolled 64 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 4, 2019
Enrollment StartJul 1, 2019
Primary CompletionJul 30, 2021
Study CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.8 years ago

Interventions

Peritonitis treatment placed in APDdevice

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

Peritonitis treatment with one exchange in CAPDdevice

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