NCT07134595Recruiting
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
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 18 Nov 2024
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- National University Health System, Singapore
- Diseases
- Chronic kidney disease
- NCT number
- NCT07134595
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 18 Nov 2024 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Peritoneal membrane failure (encapsulating peritoneal sclerosis),
Other
- Patients with BSA of ≥1.5 m2,
- Evidence of mechanical causes of low ultrafiltration capacity (hernia, peri-catheter, or genital leaks, pleuroperitoneal communication),
- Recent episode of peritonitis (within two months)
- Those who have been on hemodialysis before switching to PD in the last three weeks.
Who the study is looking for
- CKD 5D who have been on peritoneal dialysis for at least three months.
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Philippine General Hospital Coordinator of this site? Confirm its status | Manila | Philippines | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.