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.
Children 5-18 years of age
Receiving CAPD or CCPD for at least the preceding 4 weeks, and not likely to change from CAPD to CCPD during the study period
24-hour mean arterial pressure (MAP; measured by ambulatory blood pressure monitoring (ABPM) above the 95th percentile for age, sex, and height
24-hour urine output less than 200ml/day
Children under 5 years of age (as younger children are more prone to hyponatremia)
Children with systolic BP < 50th centile for age, sex, and height in the preceding 4 weeks)
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)
Known allergy to starch
Crossover
One icodextrin exchange
DrugOne 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
DrugIn two icodextin exchanges, the dwell times can vary but must be a minimum of 7 hours.
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.
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National University Health System, Singapore
Lead sponsor
The UCL Great Ormond Street Institute of Child Health
Collaborator
Children's Hospital of Fudan University
Collaborator
Philippine Children's Medical Center
Collaborator
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