Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

Phase 3

Terminated

• Conditions: Acute Renal Failure
• Interventions: Drug: ketanserin (Sufrexal); Drug: fenoldopam (Corlopam); Drug: placebo

• Registration Number: NCT00557219
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Study Start: 2008-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketanserin	ketanserin (Sufrexal)	patients receiving ketanserin infusion
Fenoldopam	fenoldopam (Corlopam)	patients receiving fenoldopam infusion
Placebo	placebo	Control group receiving placebo

Primary Outcome Measures

Name	Time	Method
cystatin C and NGAL in serum	after 24 and 48 hours from treatment start

Secondary Outcome Measures

Name	Time	Method
β2microglobulin in urine	after 24, 48 and 72 hours of treatment
frequency of renal replacement therapy	7 days after surgery
creatinine increase in serum	after 24, 48 and 72 hours of treatment

Trial Locations

Locations (1)

Department of Cardiac Anesthesiology, Medical University of Gdańsk; 🇵🇱 Gdańsk, Poland