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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorNational University Health System, Singapore

About this trial

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).

Eligibility criteria

Qualifiers

CKD 5D who have been on peritoneal dialysis for at least three months.

Disqualifiers

Patients with BSA of ≥1.5 m2,

Evidence of mechanical causes of low ultrafiltration capacity (hernia, peri-catheter, or genital leaks, pleuroperitoneal communication),

Peritoneal membrane failure (encapsulating peritoneal sclerosis),

Recent episode of peritonitis (within two months)

Trial design

Treatments tested in this trial

  • C-CAPD Prescription
  • M-CAPD Prescription

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National University Health System, Singapore

Lead sponsor

University of the Philippines Manila - Philippine General Hospital

Collaborator

Hospital Tuanku Jaafar, Seremban, Negeri Sembilan

Collaborator

Dr. Soetomo General Hospital

Collaborator

Pediatric Institute, Hospital Kuala Lumpur

Collaborator