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Effectiveness of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control Compared to a Single Icodextrin Exchange

NCT07168343 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-21

No results posted yet for this 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.

Conditions

  • Children on Chronic Peritoneal Dialysis

Interventions

DRUG

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.

DRUG

Two icodextrin exchanges

In two icodextin exchanges, the dwell times can vary but must be a minimum of 7 hours.

Sponsors & Collaborators

  • The UCL Great Ormond Street Institute of Child Health

    collaborator OTHER

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Philippine Children's Medical Center

    collaborator OTHER_GOV

  • National University Health System, Singapore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07168343 on ClinicalTrials.gov