Acute Renal FailurePhase 3NCT00557219
Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery
A Phase 3 study testing fenoldopam (Corlopam) and ketanserin (Sufrexal) in people with Acute Renal Failure, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- fenoldopam (Corlopam) and ketanserin (Sufrexal)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2008to Apr 2015
- Phase
- Phase 3
- 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
- cardiac surgery
- at least one risk factor for acute renal failure:
- oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously
- at least 60 mg furosemide/12 hours iv to maintain diuresis > 1 ml/kg/hour
Who cannot join
- refused or none consent
- chronic renal failure with chronic renal replacement therapy
- chronic increase of serum creatinine > 2 mg/dl
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Cardiac Anesthesiology, Medical University of Gdańsk
Gdansk, 80-211
About this study
Official title: Influence of Fenoldopam and Ketanserin on Function and Kidney Injury Parameters in Patients With Increased Risk of Acute Kidney Failure After Cardiac Surgery
The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.
Read the detailed description
Informed, signed consent will be obtained from the patient before surgery. In patients with acute consciousness disorders, the consent will be obtained from a legal representative and confirmed by the local court - accordingly to Polish legacy.
Patients willing to participate into the study and fulfilling at least one of two inclusion criteria will be randomly assigned to one of the three study groups. The treatment will be applied for 24 hours.
Intention to treat analysis will include comparison for differences of continuous, homogeneous distributed data with use of parametric tests, parametric or inhomogeneous distributed data - with use of nonparametric tests. The treatment effect will be assessed by comparison of the odds ratios for primary and secondary outcomes between the groups.
- Conditions
- Acute Renal Failure
- Being tested
- fenoldopam (Corlopam), placebo, ketanserin (Sufrexal)
- Keywords
- cardiac surgery, fenoldopam, ketanserin, renal replacement therapy
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fenoldopam (Corlopam)Drug
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
placeboDrug
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
ketanserin (Sufrexal)Drug
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Control group receiving placebo Receives: Drug: placebo |
| Ketanserin | Experimental | patients receiving ketanserin infusion Receives: Drug: ketanserin (Sufrexal) |
| Fenoldopam | Experimental | patients receiving fenoldopam infusion Receives: Drug: fenoldopam (Corlopam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cystatin C and NGAL in serum
Measured: after 24 and 48 hours from treatment start
Secondary outcomes (3)
β2microglobulin in urine
Measured: after 24, 48 and 72 hours of treatment
creatinine increase in serum
Measured: after 24, 48 and 72 hours of treatment
frequency of renal replacement therapy
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startApr 2008
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Main cooperator finished cooperation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej M. Kowalik, Medical University of Gdansk
- Investigators
- Katarzyna Klajbor, MD, Principal investigator, Dept. of Cardiac Anesthesiology, Medical University of GdańskRomuald Lango, MD, PhD, Study director, Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557219
- Sponsor's protocol ID
- AMG-NKEBN/225/2007
- Status last verified
- Nov 2016
- First submitted
- 9 Nov 2007
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Upon reasonable request IPD can be made available to other researcher.
Publications
Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.
PubMed 39607014
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fenoldopam and Ketanserin on Function and Kidney Injury Parameters in Patients With Increased Risk of Acute Kidney Failure After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00557219
- Acronym / sponsor ID
- AMG-NKEBN/225/2007
- Conditions
- Acute Renal Failure
- Keywords
- cardiac surgery, fenoldopam, ketanserin, renal replacement therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Main cooperator finished cooperation
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 12 Nov 2007 (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.
The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.
Detailed description
Informed, signed consent will be obtained from the patient before surgery. In patients with acute consciousness disorders, the consent will be obtained from a legal representative and confirmed by the local court - accordingly to Polish legacy.
Patients willing to participate into the study and fulfilling at least one of two inclusion criteria will be randomly assigned to one of the three study groups. The treatment will be applied for 24 hours.
Intention to treat analysis will include comparison for differences of continuous, homogeneous distributed data with use of parametric tests, parametric or inhomogeneous distributed data - with use of nonparametric tests. The treatment effect will be assessed by comparison of the odds ratios for primary and secondary outcomes between the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboControl group receiving placebo |
| Ketanserin | Experimental | Drug: ketanserin (Sufrexal)patients receiving ketanserin infusion |
| Fenoldopam | Experimental | Drug: fenoldopam (Corlopam)patients receiving fenoldopam infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cardiac surgery
- at least one risk factor for acute renal failure:
Key exclusion criteria (3 listed)
- refused or none consent
- chronic renal failure with chronic renal replacement therapy
- chronic increase of serum creatinine > 2 mg/dl
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 |
|---|---|---|
| fenoldopam (Corlopam)continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours | Drug | Fenoldopam |
| placebocontinuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours | Drug | Placebo |
| ketanserin (Sufrexal)continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours | Drug | Ketanserin |
Primary outcome
cystatin C and NGAL in serum
Time frame: after 24 and 48 hours from treatment start
3 secondary outcomes
β2microglobulin in urine
Time frame: after 24, 48 and 72 hours of treatment
creatinine increase in serum
Time frame: after 24, 48 and 72 hours of treatment
frequency of renal replacement therapy
Time frame: 7 days after surgery
Results and safety
The study was stopped early (reason given: Main cooperator finished cooperation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 39607014Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.
- home page of the Dept. of Cardiac Anesthesiology, MUGLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Upon reasonable request IPD can be made available to other researcher.
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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.
Katarzyna Klajbor, MD principal investigator
Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
Romuald Lango, MD, PhD study director
Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fenoldopam (Corlopam) and ketanserin (Sufrexal) in people with Acute Renal Failure, run by Medical University of Gdansk at 1 site in Poland.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Nov 2016. 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 Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Main cooperator finished cooperation). Results are not available in the source record.
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?
cystatin C and NGAL in serum (time frame: after 24 and 48 hours from treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00557219, which also lists 1 linked publication.
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 Nov 2016.