Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Renal Failure |
Drug: fenoldopam (Corlopam) Drug: placebo Drug: ketanserin (Sufrexal) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention |
| 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 |
- cystatin C and NGAL in serum [ Time Frame: after 24 and 48 hours from treatment start ] [ Designated as safety issue: Yes ]
- β2microglobulin in urine [ Time Frame: after 24, 48 and 72 hours of treatment ] [ Designated as safety issue: Yes ]
- creatinine increase in serum [ Time Frame: after 24, 48 and 72 hours of treatment ] [ Designated as safety issue: Yes ]
- frequency of renal replacement therapy [ Time Frame: 7 days after surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: P
Control group receiving placebo
|
Drug: placebo
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
|
|
Experimental: K
patients receiving ketanserin infusion
|
Drug: ketanserin (Sufrexal)
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
|
|
Experimental: F
patients receiving fenoldopam
|
Drug: fenoldopam (Corlopam)
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- refused or none consent
- chronic renal failure with chronic renal replacement therapy
- chronic increase of serum creatinine > 2 mg/dl
Contacts and Locations| Contact: Romuald Lango, MD, PhD | +48583492483 | rlango@gumed.edu.pl |
| Poland | |
| Department of Cardiac Anesthesiology, Medical University of Gdańsk | Recruiting |
| Gdańsk, Poland, 80-211 | |
| Department of Cadiac Anesthesiology, Medical University of Gdańsk | Recruiting |
| Gdańsk, Poland, 80-211 | |
| Principal Investigator: Katarzyna Klajbor, MD | |
| Department of Cardiac Anesthesiology, Medical University of Gdańsk | Recruiting |
| Gdańsk, Poland, 80-211 | |
| Sub-Investigator: Maciej M Kowalik, M.D., Ph.D. | |
| Principal Investigator: | Katarzyna Klajbor, MD | Dept. of Cardiac Anesthesiology, Medical University of Gdańsk |
| Study Director: | Romuald Lango, MD, PhD | Dept. of Cardiac Anesthesiology, Medical University of Gdańsk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Maciej M. Kowalik, Dr., Medical University of Gdansk |
| ClinicalTrials.gov Identifier: | NCT00557219 History of Changes |
| Other Study ID Numbers: | AMG-NKEBN/225/2007 |
| Study First Received: | November 9, 2007 |
| Last Updated: | August 4, 2012 |
| Health Authority: | Poland: Ministry of Science and Higher Education |
Keywords provided by Medical University of Gdansk:
|
cardiac surgery fenoldopam ketanserin renal replacement therapy |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases Ketanserin Fenoldopam Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Platelet Aggregation Inhibitors Hematologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasodilator Agents Dopamine Agonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013