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RECRUITING
NCT07134595
NA

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

Sponsor: National University Health System, Singapore

View on ClinicalTrials.gov

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).

Official title: A Multicenter Study Comparing Conventional Continuous Ambulatory Peritoneal Dialysis Prescription (C-CAPD) With Modified-CAPD (M-CAPD) Prescription in Delivering High Quality Goal-directed Peritoneal Dialysis in Children With End-stage Kidney Disease From Low-resource Settings: MaxED-OUT Trial

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2024-11-18

Completion Date

2026-06-30

Last Updated

2025-08-21

Healthy Volunteers

No

Interventions

OTHER

C-CAPD Prescription

The prescription for the M-CAPD therapy is the C-CAPD with an additional 1 to 2 short, low-volume, 15 to 30-minute dwells per exchange before instilling the computed full dwell volume.

OTHER

M-CAPD Prescription

The prescription for the M-CAPD therapy is the C-CAPD with an additional 1 to 2 short, low-volume, 15 to 30-minute dwells per exchange before instilling the computed full dwell volume.

Locations (1)

Philippine General Hospital

Manila, Ermita, Philippines