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

NCT07168343 | Not Yet Recruiting

• 1 other identifier: 2024-4140
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Keywords

Children; CAPD; CCPD; Icodextrin

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• 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.

  12 weeks

Secondary Outcomes (1)

• To measure caregiver burden

  12 weeks

Study Arms (2)

Group A (1-Ico)

ACTIVE COMPARATOR

Group A (One icodextrin exchange followed by two icodextrin exchanges)

Drug: One icodextrin exchange; Drug: Two icodextrin exchanges

Group B (2-Ico)

EXPERIMENTAL

Group B (Two icodextrin exchanges followed by one icodextrin exchange)

Drug: One icodextrin exchange; Drug: Two icodextrin exchanges

Interventions

One icodextrin exchange DRUG

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.

Also known as: 1-Ico

Group A (1-Ico); Group B (2-Ico)

Two icodextrin exchanges DRUG

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

Also known as: 2-Ico

Group A (1-Ico); Group B (2-Ico)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• hour mean arterial pressure (MAP; measured by ambulatory blood pressure monitoring (ABPM) above the 95th percentile for age, sex, and height
• hour urine output less than 200ml/day

You may not qualify if:

• 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

Sponsors & Collaborators

• The UCL Great Ormond Street Institute of Child Health: collaborator
• Children's Hospital of Fudan University: collaborator
• Philippine Children's Medical Center: collaborator
• National University Health System, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Central Study Contacts

Sharon Teo, Consultant

CONTACT

+65 91678482; sharon_teo@nuhs.edu.sg

Mya Than, Master of Public Health

CONTACT

+6581387599; paeumt@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Total study duration is 12 weeks. 4-week run-in period 4 weeks in one icodextrin exchange 4 weeks in two icodextrin exchanges according to randomization. There will be 3 study visits at baseline, 4 and 8 weeks.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: February 28, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)