Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00557219
Recruitment Status : Terminated (Main cooperator finished cooperation)
First Posted : November 12, 2007
Last Update Posted : November 15, 2016
Information provided by (Responsible Party):
Maciej M. Kowalik, Medical University of Gdansk

Brief 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. 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 or disease Intervention/treatment Phase
Acute Renal Failure Drug: fenoldopam (Corlopam) Drug: placebo Drug: ketanserin (Sufrexal) Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : April 2008
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Fenoldopam

Arm Intervention/treatment
Placebo Comparator: Placebo
Control group receiving placebo
Drug: placebo
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours

Experimental: Ketanserin
patients receiving ketanserin infusion
Drug: ketanserin (Sufrexal)
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours

Experimental: Fenoldopam
patients receiving fenoldopam infusion
Drug: fenoldopam (Corlopam)
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours

Primary Outcome Measures :
  1. cystatin C and NGAL in serum [ Time Frame: after 24 and 48 hours from treatment start ]

Secondary Outcome Measures :
  1. β2microglobulin in urine [ Time Frame: after 24, 48 and 72 hours of treatment ]
  2. creatinine increase in serum [ Time Frame: after 24, 48 and 72 hours of treatment ]
  3. frequency of renal replacement therapy [ Time Frame: 7 days after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • cardiac surgery
  • at least one risk factor for acute renal failure:

    1. oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00557219

Department of Cardiac Anesthesiology, Medical University of Gdańsk
Gdańsk, Poland, 80-211
Sponsors and Collaborators
Medical University of Gdansk
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

Additional Information:
Responsible Party: Maciej M. Kowalik, Dr., Medical University of Gdansk Identifier: NCT00557219     History of Changes
Other Study ID Numbers: AMG-NKEBN/225/2007
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon reasonable request IPD can be made available to other researcher.

Keywords provided by Maciej M. Kowalik, Medical University of Gdansk:
cardiac surgery
renal replacement therapy

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Antihypertensive Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Serotonin Antagonists
Serotonin Agents