N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.
Overview
- Phase
- Phase 2
- Intervention
- fenoldopam
- Conditions
- Kidney Failure, Acute
- Sponsor
- Linda F. Barr, M.D.
- Enrollment
- 80
- Primary Endpoint
- Length of post-operative hospital stay
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
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).
Investigators
Linda F. Barr, M.D.
Primary Investigator
Pulmonary Critical Care Associates of Baltimore
Eligibility 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
Arms & Interventions
NAC and fenoldopam
Both N-acetylcysteine and fenoldopam as above
Intervention: fenoldopam
NAC
N-acetylcysteine started day prior to surgery, continued through night of surgery
Intervention: N-acetylcysteine
fenoldopam
fenoldopam started at surgery continued for 24 hours
Intervention: fenoldopam
NAC and fenoldopam
Both N-acetylcysteine and fenoldopam as above
Intervention: N-acetylcysteine
Outcomes
Primary Outcomes
Length of post-operative hospital stay
Time Frame: 30-day
Length of post-operative critical care stay
Time Frame: 30-day
Creatinine clearance post-operative days 3, 14, and nadir
Time Frame: 14 day
Secondary Outcomes
- Days to post-operative creatinine clearance nadir(14 day)
- Intraoperative and post-operative pressor use (pressor-hours)(48 hour)
- Hospital costs(30-day)
- Mortality(30-day)