Actively Recruiting

Phase Not Applicable
Age: 2Years - 18Years
All Genders
NCT07134595

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

Led by National University Health System, Singapore · Updated on 2025-08-21

44

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

N

National University Health System, Singapore

Lead Sponsor

U

University of the Philippines Manila - Philippine General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 2Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with chronic kidney disease stage 5D who have been on peritoneal dialysis for at least three months.
Not Eligible

You will not qualify if you...

  • Patients with body surface area of 1.5 m2 or greater.
  • Evidence of mechanical causes of low ultrafiltration capacity such as hernia, peri-catheter or genital leaks, or pleuroperitoneal communication.
  • Peritoneal membrane failure including encapsulating peritoneal sclerosis.
  • Recent episode of peritonitis within two months.
  • Those who have been on hemodialysis before switching to peritoneal dialysis in the last three weeks.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Philippine General Hospital

Manila, Ermita, Philippines, 1000 Metro Manila

Actively Recruiting

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Research Team

S

Sharon Teo, Consultant

CONTACT

M

Mya Than

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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