Status:
NOT_YET_RECRUITING
Effectiveness of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control Compared to a Single Icodextrin Exchange
Lead Sponsor:
National University Health System, Singapore
Collaborating Sponsors:
The UCL Great Ormond Street Institute of Child Health
Children's Hospital of Fudan University
Conditions:
Children on Chronic Peritoneal Dialysis
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief 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 increas...
Detailed Description
1. Background and Rationale Fluid overload and hypertension are among the most prevalent and clinically significant complications in pediatric patients receiving chronic peritoneal dialysis (PD). In c...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07168343
Start Date
November 1 2025
End Date
June 30 2028
Last Update
September 18 2025
Active Locations (1)
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1
National University Hospital
Singapore, Singapore