Effectiveness of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control Compared to … (NCT07168343) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effectiveness of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control Compared to a Single Icodextrin Exchange
Singapore10 participantsStarted 2026-02-28
Plain-language 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.
Who can participate
Age range5 Years – 18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. Pregnant women
✕
What they're measuring
1
Ultrafiltration efficiency
Timeframe: 12 weeks
2
The solute clearance adequacy
Timeframe: 12 weeks
Trial details
NCT IDNCT07168343
SponsorNational University Health System, Singapore
. 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