An Investigation of N-Acetylcysteine and Fenoldopam as Renal Protection Agents for 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. 

Official Title

Conditions

• Kidney Failure, Acute
• Kidney Failure, Chronic
• Cardiac Surgical Procedures

Study Type

Interventional

Study Design

Prevention, Randomised, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

• Length of post-operative hospital stay
• Length of post-operative critical care stay
• Creatinine clearance post-operative days 3, 14, and nadir

Secondary Outcome Measures:

• Days to post-operative creatinine clearance nadir
• Intraoperative and post-operative pressor use (pressor-hours)
• Hospital costs

Detailed Description:

This is a randomised, 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 Start

May 2002

Eligibility & Criteria

• Ages Eligible for Study: 18 years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No

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

Total Enrolment

80

Contact Details

Linda F Barr, MD
Pulmonary and Critical Care Assoc. of Baltimore