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Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

NCT00557219 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-11-15

No results posted yet for this study

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.

Conditions

  • Acute Renal Failure

Interventions

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

Sponsors & Collaborators

  • Medical University of Gdansk

    lead OTHER

Principal Investigators

  • Katarzyna Klajbor, MD · Dept. of Cardiac Anesthesiology, Medical University of Gdańsk

  • Romuald Lango, MD, PhD · Dept. of Cardiac Anesthesiology, Medical University of Gdańsk

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557219 on ClinicalTrials.gov