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

NCT07134595 | Recruiting

• 1 other identifier: UPMREB 2024-0138-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine the ultrafiltration efficiency by measuring the following:
2. 2.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),
3. 3.Change in the number of blood pressure medications before and after the intervention,
4. 4.Absolute and relative fluid overload using bioimpedance analyzer (BIA),
5. 5.Mean daily ultrafiltration (UF) or Total 24-h UF,
6. 6.Residual kidney function: 24-hour urine output,
7. 7.Glucose exposure
8. 8.To determine the solute clearance adequacy by measuring the following:
9. 9.Serum sodium, chloride, potassium, bicarbonate, serum albumin, calcium, and hemoglobin,
10. 10.Phosphate clearance
11. 11.Renal and peritoneal Kt/Vurea
12. 12.Normalized protein catabolic rate (nPCR)
13. 13.To measure caregiver burden using a Paediatric Renal Caregiver Burden Scale (PR-CBS).

Conditions

Children on Chronic Peritoneal Dialysis

Keywords

M-CAPD; C-CAPD; ESKD; Children; Low-resource settings

Outcome Measures

Primary Outcomes (2)

• Ultrafiltration efficiency

  Ultrafiltration (UF): Assessed clinically through blood pressure, presence of edema or crackles, reduced need for antihypertensive medications, residual kidney function, and mean daily UF.

  12 weeks

• The solute clearance adequacy

  Toxin Removal: Evaluated by comparing pre- and post-intervention levels of electrolytes and urea clearance, calculated using the Kt/V formula.

  12 weeks

Secondary Outcomes (1)

• To measure caregiver burden

  12 weeks

Study Arms (2)

C-CAPD therapy

ACTIVE COMPARATOR

The prescription for the C-CAPD therapy is as follows: 1. PD solution containing 1.5%, 2.5% dextrose (or its equivalent, for example, 2.3%), 4.25%. 2. Full fill volume computed as 1100-1400 ml/m2 as described by Fischbach et al. \[19\], 3. Day-time and night-time dwell time ranging from 3 to 6 hours 4. Two to 3-daytime exchanges with or without night exchange 5. 8 to 10 hours of overnight dwell

Other: C-CAPD Prescription; Other: M-CAPD Prescription

M-CAPD Therapy

EXPERIMENTAL

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: C-CAPD Prescription; Other: M-CAPD Prescription

Interventions

C-CAPD Prescription OTHER

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.

Also known as: M-CAPD Prescription

C-CAPD therapy; M-CAPD Therapy

M-CAPD Prescription OTHER

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.

C-CAPD therapy; M-CAPD Therapy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)
• Those who have been on hemodialysis before switching to PD in the last three weeks.

Sponsors & Collaborators

• National University Health System, Singapore: lead
• 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

Study Sites (1)

Philippine General Hospital

Manila, Ermita, 1000 Metro Manila, Philippines

RECRUITING

Study Officials

• Hui Kim Yap, Professor

  National University Health System, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Teo, Consultant

CONTACT

+65 91678482; sharon_teo@nuhs.edu.sg

Mya Than

CONTACT

+65 67722460; than_mya@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: A computer-generated random number will be assigned to patients to undergo either C-CAPD or M-CAPD therapy. After randomization, a 2-week run-in period will precede the assigned CAPD prescription. They will perform this assigned PD prescription for 2 consecutive months. After which, a 2-week wash-out period will be allowed before crossing over to either C-CAPD or M-CAPD. The total intervention time is 12 weeks.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 21, 2025
• Study Start: November 18, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)