Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

November 14, 2016 updated by: Maciej M. Kowalik, Medical University of Gdansk

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gdańsk, Poland, 80-211
        • Department of Cardiac Anesthesiology, Medical University of Gdańsk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Control group receiving placebo
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
EXPERIMENTAL: Ketanserin
patients receiving ketanserin infusion
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
EXPERIMENTAL: Fenoldopam
patients receiving fenoldopam infusion
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cystatin C and NGAL in serum
Time Frame: after 24 and 48 hours from treatment start
after 24 and 48 hours from treatment start

Secondary Outcome Measures

Outcome Measure
Time Frame
β2microglobulin in urine
Time Frame: after 24, 48 and 72 hours of treatment
after 24, 48 and 72 hours of treatment
creatinine increase in serum
Time Frame: after 24, 48 and 72 hours of treatment
after 24, 48 and 72 hours of treatment
frequency of renal replacement therapy
Time Frame: 7 days after surgery
7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Katarzyna Klajbor, MD, Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
  • Study Director: Romuald Lango, MD, PhD, Dept. of Cardiac Anesthesiology, Medical University of Gdańsk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (ESTIMATE)

November 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon reasonable request IPD can be made available to other researcher.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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