An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery

November 6, 2014 updated by: Linda F. Barr, M.D.

N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.

Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blinded, placebo-controlled trial to evaluate fenoldopam and N-acetylcysteine (NAC) individually, and together, as renal protective agents for patients with renal insufficiency undergoing heart surgery. Subjects have chronic renal insufficiency with creatinine clearance (CrCl) </= 40cc/min but not on pre-operative dialysis, and receive: NAC 600 mg by mouth (po) twice a day (bid) or placebo starting 24 hours pre-operative and continuing through the day of surgery; and/or fenoldopam 0.1 mcg/kg/min intravenous (IV) or saline placebo at anesthetic induction and continuing for 48 hours. Outcome data include: nadir, post-operative day 3 and post-operative day 14 CrCl, time to CrCl nadir, length of Intensive Care Unit (ICU) stay, length of post-operative hospital stay, hospital costs, mortality, and the need for hemodialysis. Intraoperative and post-operative pressor use is being monitored. The enrollment will include 80 patients (20 in each group).

Study Type

Interventional

Enrollment

80

Phase

  • Phase 2

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:

  • Chronic creatinine clearance </= 40cc/h
  • Pre-operative cardiac surgery

Exclusion Criteria:

  • Pre-operative ongoing dialysis
  • Nausea and vomiting
  • Uncontrolled glaucoma
  • Allergy to metabisulfite
  • Enrollment in another clinical study within 30 days
  • Pregnancy
  • Acute renal failure

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: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Placebo
EXPERIMENTAL: NAC
N-acetylcysteine started day prior to surgery, continued through night of surgery
Drug: N-acetylcysteine
Other Names:
  • Mucomyst
EXPERIMENTAL: fenoldopam
fenoldopam started at surgery continued for 24 hours
Drug: fenoldopam
Other Names:
  • Corlopam
EXPERIMENTAL: NAC and fenoldopam
Both N-acetylcysteine and fenoldopam as above
Drug: N-acetylcysteine
Other Names:
  • Mucomyst
Drug: fenoldopam
Other Names:
  • Corlopam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of post-operative hospital stay
Time Frame: 30-day
30-day
Length of post-operative critical care stay
Time Frame: 30-day
30-day
Creatinine clearance post-operative days 3, 14, and nadir
Time Frame: 14 day
14 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30-day
30-day
Days to post-operative creatinine clearance nadir
Time Frame: 14 day
14 day
Intraoperative and post-operative pressor use (pressor-hours)
Time Frame: 48 hour
48 hour
Hospital costs
Time Frame: 30-day
30-day

Collaborators and Investigators

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

Sponsor

Linda F. Barr, M.D.

Collaborators

Abbott

Investigators

  • Principal Investigator: Linda F Barr, MD, Pulmonary and Critical Care Assoc. of Baltimore

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.

General Publications

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

May 1, 2002

Primary Completion (ACTUAL)

March 1, 2006

Study Completion (ACTUAL)

March 1, 2006

Study Registration Dates

First Submitted

July 14, 2005

First Submitted That Met QC Criteria

July 20, 2005

First Posted (ESTIMATE)

July 21, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2014

Last Update Submitted That Met QC Criteria

November 6, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REPORT

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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