N/A
N=64
Treatment of Peritonitis in Automated Peritoneal Dialysis
Secondary Peritonitis
Bottom Line
View on ClinicalTrials.gov: NCT04077996 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Peritonitis Resolved — 26; 29 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peritonitis treatment placed in APD (Device); Peritonitis treatment with one exchange in CAPD (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad de Colima
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peritonitis Resolved |
26; 29 | <0.05 sig |
| SECONDARY Death of Patient |
2; 2 | <0.05 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04077996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.