Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

This study is currently recruiting participants.
Verified August 2012 by Medical University of Gdansk
Sponsor:
Information provided by (Responsible Party):
Maciej M. Kowalik, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT00557219
First received: November 9, 2007
Last updated: August 4, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • cystatin C and NGAL in serum [ Time Frame: after 24 and 48 hours from treatment start ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557219

Contacts
Contact: Romuald Lango, MD, PhD +48583492483 rlango@gumed.edu.pl

Locations
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.         
Sponsors and Collaborators
Medical University of Gdansk
Investigators
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 April 21, 2014