Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

Medical University of Gdansk

Status and phase: Terminated; Phase 3

Conditions: Acute Renal Failure

Treatments: Drug: fenoldopam (Corlopam); Drug: ketanserin (Sufrexal); Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00557219

AMG-NKEBN/225/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Control group receiving placebo

Treatment:

Drug: placebo

Ketanserin

Experimental group

Description:

patients receiving ketanserin infusion

Treatment:

Drug: ketanserin (Sufrexal)

Fenoldopam

Experimental group

Description:

patients receiving fenoldopam infusion

Treatment:

Drug: fenoldopam (Corlopam)