NCT07466459

Brief Summary

Children receiving chronic haemodialysis are typically treated with dialysis machines designed for adult patients. As a result, some devices do not allow the ideal blood or dialysate flow rates to be set for paediatric use. In addition, the optimal dialysate-to-blood flow ratio for maximising solute removal while minimising water consumption remains poorly defined. The aim of this study is to quantify the dialyser extraction ratio and clearance across different dialysis modalities and a range of dialysate-to-blood flow ratios. Blood and dialysate samples are collected at the blood inlet, blood outlet, and dialysate outlet lines, and concentrations of various uraemic toxins-spanning a range of molecular weights-are measured to calculate solute clearances.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 13, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

February 12, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

hemodialysisdialyser clearancewater usageextraction ratiopediatric

Outcome Measures

Primary Outcomes (1)

  • Extraction Ratio

    Extraction ratio is calculated from dialyzer inlet and outlet toxin concentrations for different dialysis settings. Dialysis efficiency, based on extration ratio, is related to the corresponding water usage.

    During the first hour of one midweek dialysis session, different dialysis flows and modalities are set for the time needed to take the samples.

Study Arms (1)

dialysis settings

EXPERIMENTAL

In each participant and in a consecutive way, different dialysis modalities and dialysate to blood flow ratios are set.

Other: blood and dialysate sampling

Interventions

For ach setting, blood and dialysate samples are taken in order to be able to calculate the extraction ratio and dialyser clearance.

dialysis settings

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • not older than 18 years old
  • at least three months of stable hemodialysis

You may not qualify if:

  • a non well-functioning vascular access
  • infections at the study week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital, Nephrology

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

March 12, 2026

Study Start

November 13, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations