PediatricOptiPedNCT07466459
Optimisation of Solute Removal and Water Usage in Paediatric Haemodialysis
A study testing blood and dialysate sampling in people with Pediatric and Efficiency, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric, Efficiency, Hemodialysis Patient
- What is being tested?
- blood and dialysate sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- not older than 18 years old
- at least three months of stable hemodialysis
Who cannot join
- a non well-functioning vascular access
- infections at the study week
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Pediatric, Efficiency, Hemodialysis Patient, Hemodialysis Treatment
- Being tested
- blood and dialysate sampling
- Keywords
- hemodialysis, dialyser clearance, water usage, extraction ratio, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood and dialysate samplingOther
For ach setting, blood and dialysate samples are taken in order to be able to calculate the extraction ratio and dialyser clearance.
| Study group | Role | What they receive |
|---|---|---|
| dialysis settings | Experimental | In each participant and in a consecutive way, different dialysis modalities and dialysate to blood flow ratios are set. Receives: Other: blood and dialysate sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the first hour of one midweek dialysis session, different dialysis flows and modalities are set for the time needed to take the samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start13 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466459
- Sponsor's protocol ID
- ONZ-2025-0402
- Acronym
- OptiPed
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Solute Removal and Water Usage in Paediatric Haemodialysis
- ClinicalTrials.gov ID
- NCT07466459
- Acronym / sponsor ID
- OptiPed / ONZ-2025-0402
- Conditions
- Pediatric, Efficiency, Hemodialysis Patient, Hemodialysis Treatment
- Keywords
- hemodialysis, dialyser clearance, water usage, extraction ratio, pediatric
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dialysis settings | Experimental | Other: blood and dialysate samplingIn each participant and in a consecutive way, different dialysis modalities and dialysate to blood flow ratios are set. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- not older than 18 years old
- at least three months of stable hemodialysis
Key exclusion criteria (2 listed)
- a non well-functioning vascular access
- infections at the study week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood and dialysate samplingFor ach setting, blood and dialysate samples are taken in order to be able to calculate the extraction ratio and dialyser clearance. | Other | dialysis settings |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood and dialysate sampling in people with Pediatric and Efficiency, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.