Optimisation of Solute Removal and Water Usage in Paediatric Haemodialysis (OptiPed)

March 9, 2026 updated by: University Hospital, Ghent

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Children undergoing haemodialysis are enrolled in the study. During a mid-week dialysis session, three dialysis modalities are applied sequentially for 10-15 minutes each: haemodialysis (HD), predilution haemodiafiltration (pre-HDF), and postdilution haemodiafiltration (post-HDF). For each modality, the dialysate-to-blood flow ratio is adjusted to approximately 1.0, 1.5, and 2.0.

For each setting, blood samples are collected from the blood inlet and outlet lines, and dialysate samples are taken from the spent dialysate line. All sampling is performed within the first hour of the dialysis session.

All samples are analysed for a range of uraemic toxins, including small water-soluble solutes, middle molecules, and protein-bound toxins. Using inlet and outlet blood concentrations, the extraction ratio is calculated for each setting. Based on the dialysate flow rate, total water usage for a full dialysis session is estimated. Together, these calculations allow determination of the optimal dialysate-to-blood flow ratio that provides the highest dialyser clearance with the lowest relative water consumption.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital, Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dialysis settings
In each participant and in a consecutive way, different dialysis modalities and dialysate to blood flow ratios are set.
Other: blood and dialysate sampling
For ach setting, blood and dialysate samples are taken in order to be able to calculate the extraction ratio and dialyser clearance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extraction Ratio
Time Frame: During the first hour of one midweek dialysis session, different dialysis flows and modalities are set for the time needed to take the samples.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2025-0402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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