NCT00557219

Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

Influence of Fenoldopam and Ketanserin on Function and Kidney Injury Parameters in Patients With Increased Risk of Acute Kidney Failure After Cardiac Surgery

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Renal Failure

Interventions

Type	Name	Description
DRUG	fenoldopam (Corlopam)	continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
DRUG	placebo	continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
DRUG	ketanserin (Sufrexal)	continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours

Timeline

• Start date: 2008-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2007-11-12
• Last updated: 2016-11-15

Locations

1 site across 1 country: Poland