Renal FailureNCT00752804
Uremic Toxins in the ICU: Patients After Cardiac Surgery
A study testing Dialysis during 4 hours, Dialysis during 6 hours and Dialysis during 8 hours in people with Renal Failure, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients after cardiac surgery.The sampling of blood and dialysate will be done during dialyses with different durations (4, 6 and 8h) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Dialysis during 4 hours, Dialysis during 6 hours and Dialysis during 8 hours
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jul 2008to 31 Dec 2013
- 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
- ICU patients after cardiac surgery with acute renal failure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Kinetics of Uremic Toxins in the ICU Patients With Acute Renal Failure, in Order to Optimize the Dialysis Dose: Patients After Cardiac Surgery
Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients after cardiac surgery.The sampling of blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)
- Conditions
- Renal Failure
- Being tested
- Dialysis during 4 hours, Dialysis during 6 hours, Dialysis during 8 hours
- Keywords
- ICU patients with acute renal failure after cardiac surgery
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysis during 4 hoursProcedure or surgery
Blood and dialysate sampling
Dialysis during 6 hoursProcedure or surgery
Blood and dialysate sampling
Dialysis during 8 hoursProcedure or surgery
Blood and dialysate sampling
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dialysis during 4 hours Receives: Procedure: Dialysis during 4 hours |
| 2 | Active comparator | Dialysis during 6 hours Receives: Procedure: Dialysis during 6 hours |
| 3 | Active comparator | Dialysis during 8 hours Receives: Procedure: Dialysis during 8 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxin removal
Measured: During dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study start31 Jul 2008
- Primary completion4 Oct 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- 9 participants (actual)
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
- NCT00752804
- Sponsor's protocol ID
- 2008/374
- Status last verified
- Dec 2022
- First submitted
- 12 Sep 2008
- 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
- Study of the Kinetics of Uremic Toxins in the ICU Patients With Acute Renal Failure, in Order to Optimize the Dialysis Dose: Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00752804
- Acronym / sponsor ID
- 2008/374
- Conditions
- Renal Failure
- Keywords
- ICU patients with acute renal failure after cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 31 Jul 2008 (actual)
- Primary completion
- 4 Oct 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 15 Sep 2008 (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.
Study of the kinetics of uremic toxins in the ICU patients with acute renal failure, in order to optimize the dialysis dose: patients after cardiac surgery.The sampling of blood and dialysate will be done during dialyses with different durations (4, 6 and 8h)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Dialysis during 4 hoursDialysis during 4 hours |
| 2 | Active comparator | Procedure: Dialysis during 6 hoursDialysis during 6 hours |
| 3 | Active comparator | Procedure: Dialysis during 8 hoursDialysis during 8 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients after cardiac surgery with acute renal failure
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 |
|---|---|---|
| Dialysis during 4 hoursBlood and dialysate sampling | Procedure or surgery | 1 |
| Dialysis during 6 hoursBlood and dialysate sampling | Procedure or surgery | 2 |
| Dialysis during 8 hoursBlood and dialysate sampling | Procedure or surgery | 3 |
Primary outcome
Toxin removal
Time frame: During dialysis
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.
- Website of the University Hospital GhentLink 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 Dialysis during 4 hours, Dialysis during 6 hours and Dialysis during 8 hours in people with Renal Failure, 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 1 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?
Toxin removal (time frame: During dialysis). 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.