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Enrolling by invitation NCT07466459

Optimisation of Solute Removal and Water Usage in Paediatric Haemodialysis

No phase Interventional Pediatric Efficiency Hemodialysis Patient Hemodialysis Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood and dialysate sampling.
Who it may be relevant to
Registry conditions: Pediatric, Efficiency, Hemodialysis Patient, Hemodialysis Treatment. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Ghent University Hospital, Nephrology — Ghent

Identifiers

NCT: NCT07466459 · ONZ-2025-0402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗