End-stage Renal DiseaseNCT01445366
Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
A study testing High volume post dilution hemodiafiltration and high flux hemodialysis in people with End-stage Renal Disease, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This is a prospective cross-over study including 10 stable hemodialysis patients with chronic kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis sessions at midweek. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- High volume post dilution hemodiafiltration and high flux hemodialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2012to 29 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease (CKD) stage 5 with hemodialysis or hemodiafiltration treatment for more than three months.
- No vascular access related problems (Arteriovenous (A/V) fistula, graft or bi-flow catheter)
- Double needle/lumen vascular access
- No ongoing infection
- Singed informed consent form
- Known HIV or active hepatitis B or C infection (Positive Polymerisation Chain Reaction (PCR))
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- Pregnancy
- Unstable clinical condition (e.g. cardiac or vascular instability)
- Known coagulation problems
- Patients participating in another study interfering with the planned study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective cross-over study including 10 stable hemodialysis patients with chronic kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis sessions at midweek.
During one session, the patient will be dialyzed during 4 hours with high volume post dilution hemodiafiltration (HDF) with an FX800 hemodialyzer (Fresenius Medical Care) and a blood flow of 300mL/min, dialysate flow of 500mL/min, and substitution flow of 75mL/min.
Read more
During the other midweek session, the patient will be dialyzed during 8 hours with high flux hemodialysis (HD) with an FX80 hemodialyzer (Fresenius Medical Care) and a blood flow of 200mL/min and a dialysate flow of 500mL/min.
The HDF and HD sessions will be randomized. Blood samples will be drawn pre and post dialysis from the arterial blood line, and after 30min after dialysis start, a blood sample will be drawn from the inlet and outlet line.
At the dialysate outlet line, partial dialysate collection is performed at the outlet line.
Blood and dialysate samples will be analyzed for a broad range of retention solutes like small and water soluble solutes, middle molecules, and protein bound solutes.
These data will be further used to calculate solute removal and evaluate any differences between the solute removal during high volume post dilution HDF and high flux HD.
- Conditions
- End-stage Renal Disease
- Being tested
- High volume post dilution hemodiafiltration, high flux hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High volume post dilution hemodiafiltrationDevice
The midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session.
high flux hemodialysisDevice
The midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session.
| Study group | Role | What they receive |
|---|---|---|
| Patients with end-stage renal disease | Experimental | Not described Receives: Device: High volume post dilution hemodiafiltration; Device: high flux hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with hemodialysis (HD). Pre to post dialysis during 4h post dilution hemodiafiltration (HDF).
Measured: During 4 hours
Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with HD. Pre to post dialysis during 8h high flux HD.
Measured: During 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startApr 2012
- Primary completion29 Sep 2014
- Study completion29 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond Vanholder, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445366
- Sponsor's protocol ID
- 2011/591
- Status last verified
- Dec 2022
- First submitted
- 22 Sep 2011
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis
- ClinicalTrials.gov ID
- NCT01445366
- Acronym / sponsor ID
- 2011/591
- Conditions
- End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- 29 Sep 2014 (actual)
- Study completion
- 29 Sep 2014 (actual)
- First posted
- 3 Oct 2011 (estimated)
- 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.
This is a prospective cross-over study including 10 stable hemodialysis patients with chronic kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis sessions at midweek.
During one session, the patient will be dialyzed during 4 hours with high volume post dilution hemodiafiltration (HDF) with an FX800 hemodialyzer (Fresenius Medical Care) and a blood flow of 300mL/min, dialysate flow of 500mL/min, and substitution flow of 75mL/min.
During the other midweek session, the patient will be dialyzed during 8 hours with high flux hemodialysis (HD) with an FX80 hemodialyzer (Fresenius Medical Care) and a blood flow of 200mL/min and a dialysate flow of 500mL/min.
The HDF and HD sessions will be randomized. Blood samples will be drawn pre and post dialysis from the arterial blood line, and after 30min after dialysis start, a blood sample will be drawn from the inlet and outlet line.
At the dialysate outlet line, partial dialysate collection is performed at the outlet line.
Blood and dialysate samples will be analyzed for a broad range of retention solutes like small and water soluble solutes, middle molecules, and protein bound solutes.
These data will be further used to calculate solute removal and evaluate any differences between the solute removal during high volume post dilution HDF and high flux HD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with end-stage renal disease | Experimental | Device: High volume post dilution hemodiafiltration, Device: high flux hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Chronic kidney disease (CKD) stage 5 with hemodialysis or hemodiafiltration treatment for more than three months.
- No vascular access related problems (Arteriovenous (A/V) fistula, graft or bi-flow catheter)
- Double needle/lumen vascular access
- No ongoing infection
- Singed informed consent form
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| High volume post dilution hemodiafiltrationThe midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session. | Device | Patients with end-stage renal disease |
| high flux hemodialysisThe midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session. | Device | Patients with end-stage renal disease |
Primary outcome
Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
Time frame: During 4 hours
Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with hemodialysis (HD). Pre to post dialysis during 4h post dilution hemodiafiltration (HDF).
Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples.
Time frame: During 8 hours
Blood and dialysate samples will be analyzed for the concentration of small water soluble solutes, protein bound solutes and middle molecules. Concentrations will be used to calculate different adequacy parameters in order to compare HDF with HD. Pre to post dialysis during 8h high flux HD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Raymond Vanholder, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High volume post dilution hemodiafiltration and high flux hemodialysis in people with End-stage Renal Disease, 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 10 inclusion and 0 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: finished, as of the sponsor's last update on 15 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Uremic retention solute concentrations from pre and post dialysis blood samples,dialyzer inlet and outlet blood samples,and spent dialysate samples. (time frame: During 4 hours). The study lists 2 primary outcomes in all. 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 15 Dec 2022.