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

Condition(s) targeted: Kidney Failure, Acute; Kidney Failure, Chronic; Cardiac Surgical Procedures

Intervention: N-acetylcysteine (Drug); fenoldopam (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Linda F. Barr, M.D.

Official(s) and/or principal investigator(s):
Linda F Barr, MD, Principal Investigator, Affiliation: Pulmonary and Critical Care Assoc. of Baltimore

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome:

Length of post-operative hospital stay

Length of post-operative critical care stay

Creatinine clearance post-operative days 3, 14, and nadir

Secondary outcome:

Days to post-operative creatinine clearance nadir

Intraoperative and post-operative pressor use (pressor-hours)

Hospital costs

Mortality

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)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Chronic creatinine clearance

- 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

Starting date: May 2002
Last updated: November 6, 2014