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).
CKD 5D who have been on peritoneal dialysis for at least three months.
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)
Crossover
C-CAPD Prescription
Other interventionThe 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.
M-CAPD Prescription
Other interventionThe 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.
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.
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.
To measure caregiver burden
Caregiver burden will be measured by using a Paediatric Renal Caregiver Burden Scale (PR-CBS) Using the Caregiver Burden Scale (1-5, with higher scores indicating greater burden), we will assess whether the additional exchange is perceived as an increased burden or a relief, particularly if clinical improvements in the child are observed.
Click on the lead sponsor to view all of their trials.
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
