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

Recruiting · NCT07134595 · Interventional (participants receive a specific treatment) · Lead sponsor: National University Health System, Singapore

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Chronic kidney disease

Interventions studied

C-CAPD PrescriptionM-CAPD Prescription

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).

Who can take part

Age range

2 Years to 18 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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

Exclusion criteria

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.

Where it is running

1 location listed.

Philippine General Hospital - Manila, Ermita, Philippines

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →