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Optimisation of Solute Removal and Water Usage in Paediatric Haemodialysis

Optimisation of Solute Removal and Water Usage in Paediatric Haemodialysis

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07466459
Acronym
OptiPed
Enrollment
10
Registered
2026-03-12
Start date
2025-11-13
Completion date
2026-12-31
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Efficiency, Hemodialysis Patient, Hemodialysis Treatment, Pediatric

Keywords

hemodialysis, dialyser clearance, water usage, extraction ratio, pediatric

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.

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

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

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Extraction RatioDuring 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026