Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

Phase 3TerminatedNCT00557219

Medical University of Gdansk60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Acute Renal Failure

Interventions

fenoldopam (Corlopam)DRUG

continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours

placeboDRUG

continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours

ketanserin (Sufrexal)DRUG

continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Cardiac Anesthesiology, Medical University of Gdańsk

Gdansk, Poland

Outcomes

Primary Outcomes

cystatin C and NGAL in serum

Time frame: after 24 and 48 hours from treatment start

Secondary Outcomes

β2microglobulin in urine

Time frame: after 24, 48 and 72 hours of treatment

creatinine increase in serum

Time frame: after 24, 48 and 72 hours of treatment

frequency of renal replacement therapy

Time frame: 7 days after surgery

Data from ClinicalTrials.gov

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