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

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).

Conditions

• Children on Chronic Peritoneal Dialysis

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.

Sponsors & Collaborators

• University of the Philippines Manila - Philippine General Hospital

  collaborator OTHER

• Hospital Tuanku Jaafar, Seremban, Negeri Sembilan

  collaborator UNKNOWN

• Dr. Soetomo General Hospital

  collaborator OTHER_GOV

• Pediatric Institute, Hospital Kuala Lumpur

  collaborator UNKNOWN

• National University Health System, Singapore

  lead OTHER

Principal Investigators

• Hui Kim Yap, Professor · National University Health System, Singapore

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-18

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Philippines

Study Locations