Patients with abnormal kidney function are at increased risk of 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.

Condition	Intervention	Phase
Kidney Failure, Acute Kidney Failure, Chronic Cardiac surgical procedures	Drug: N-acetylcysteine  Drug: fenoldopam	Phase II

Further Study Details: 

Primary Outcomes: Length of post-operative hospital stay; Length of post-operative critical care stay; Creatinine clearance post-operative days 3, 14, and nadir
Secondary Outcomes: Days to post-operative creatinine clearance nadir; Intraoperative and post-operative pressor use (pressor-hours); Hospital costs; Mortality
Expected Total Enrollment:  80

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).

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00122018

Linda F Barr, MD      410-321-5651    lbarr@pccabpa.com
Ellen Brahim      410-825-6456 

Maryland
      St. Joseph Medical Center, Baltimore,  Maryland,  21204,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  REPORT
Record last reviewed:  February 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122018
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26