Trial | NCT00122018  Report issue

Title

An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery
N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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.
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)
Study Started
May 31
2002
Primary Completion
Mar 31
2006
Study Completion
Mar 31
2006
Last Update
Nov 07
2014
Estimate

Drug N-acetylcysteine

  • Other names: Mucomyst

Drug fenoldopam

  • Other names: Corlopam

NAC Experimental

N-acetylcysteine started day prior to surgery, continued through night of surgery

fenoldopam Experimental

fenoldopam started at surgery continued for 24 hours

NAC and fenoldopam Experimental

Both N-acetylcysteine and fenoldopam as above

Control Placebo Comparator

Placebo

Criteria 

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
No Results Posted