Clinical Trial

Comparing Conventional Continuous Ambulatory Peritoneal Dialysis Prescription (C-CAPD) With Modified-CAPD (M-CAPD) Prescription in Children With End-stage Kidney Disease From Low-resource Settings

Recruiting
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Record status
This record was last updated August 21, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to compare modified CAPD (M-CAPD) and conventional CAPD (C-CAPD) in terms of delivering high-quality, goal-directed PD as well as avoiding resource wastage in prevalent ESKD patients aged 2 to ≤18 years using a randomized cross-over study design for one year. This study hypothesizes that M-CAPD will have better ultrafiltration and solute clearance than C-CAPD. Specific objectives 1. To determine the ultrafiltration efficiency by measuring the following: 1. Clinical parameters: blood pressure, weight, evidence of fluid overload by the presence of edema, abnormal heart sounds (S3 gallop), lung crackles or rales, increased heart rate (tachycardia), rapid breathing (tachypnea), 2. Change in the number of blood pressure medications before and after the intervention, 3. Absolute and relative fluid overload using bioimpedance analyzer (BIA), 4. Mean daily ultrafiltration (UF) or Total 24-h UF, 5. Residual kidney function: 24-hour urine output, 6. Glucose exposure 2. To determine the solute clearance adequacy by measuring the following: 1. Serum sodium, chloride, potassium, bicarbonate, serum albumin, calcium, and hemoglobin, 2. Phosphate clearance 3. Renal and peritoneal Kt/Vurea 4. Normalized protein catabolic rate (nPCR) 3. To measure caregiver burden using a Paediatric Renal Caregiver Burden Scale (PR-CBS).
Trial Details
NCT Number NCT07134595
Lead Sponsor National University Health System, Singapore
Collaborators: University of the Philippines Manila - Philippine General Hospital, Hospital Tuanku Jaafar, Seremban, Negeri Sembilan, Dr. Soetomo General Hospital, Pediatric Institute, Hospital Kuala Lumpur
Conditions Children on Chronic Peritoneal Dialysis
Enrollment 44 participants
Start Date 2024-11-18
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-21