One icodextrin exchange: One icodextrin fill volume of 550ml/m2 body surface area which is optimal for most paediatric patients is recommended. The minimum dwell time for an icodextrin exchange will be 7 hours, and range between 7-10 hours.
Two icodextrin exchanges: In two icodextin exchanges, the dwell times can vary but must be a minimum of 7 hours.
Study summary
Fluid overload and hypertension are prevalent in children undergoing chronic peritoneal dialysis (PD), especially in low- and middle-income countries (LMICs). These complications often lead to increased hospitalizations, higher medication use, and, in some cases, conversion to hemodialysis. Icodextrin is used to enhance ultrafiltration (UF) and reduce glucose exposure, but its effectiveness in children with a single long dwell has been inconsistent. Preliminary observations suggest that shorter, twice-daily icodextrin exchanges may improve UF and blood pressure (BP) control. However, no randomized trial has evaluated this approach in pediatric patients.
Eligibility
Sex
ALL
Min age
5 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
1. Children 5-18 years of age
2. Receiving CAPD or CCPD for at least the preceding 4 weeks, and not likely to change from CAPD to CCPD during the study period
3. 24-hour mean arterial pressure (MAP; measured by ambulatory blood pressure monitoring (ABPM) above the 95th percentile for age, sex, and height
4. 24-hour urine output less than 200ml/day
Exclusion Criteria:
1. Children under 5 years of age (as younger children are more prone to hyponatremia)
2. Children with systolic BP \< 50th centile for age, sex, and height in the preceding 4 weeks)
3. Children who are polyuric or those prone to hypotension (defined as \> 2 episodes of systolic BP \< 5th centile in the 4 weeks preceding the study)
4. Known allergy to starch
5. Pregnant women
6. Patients with maltose or isomaltose intolerance, glycogen storage disease, pre-existing severe lactic acidosis, uncorrectable mechanical defects that prevent effective PD or increase the risk of infection and documented loss of peritoneal function or extensive adhesions that compromise peritoneal function
Primary outcome measure(s)
Ultrafiltration efficiency — 12 weeks 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 — 12 weeks Toxin Removal: Evaluated by comparing pre- and post-intervention levels of electrolytes and urea clearance, calculated using the Kt/V formula.
Trial sites (1)
Facility
City
Region
Status
National University Hospital
Singapore
Singapore
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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