An Investigation of N-Acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery - Full Text View

Sponsors and Collaborators:	Pulmonary Critical Care Associates of Baltimore Abbott
Information provided by:	Pulmonary Critical Care Associates of Baltimore
ClinicalTrials.gov Identifier:	NCT00122018

Purpose

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.

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

MedlinePlus related topics: Critical Care Heart Surgery Kidney Failure

Drug Information available for: Acetylcysteine Fenoldopam mesylate Fenoldopam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Further study details as provided by Pulmonary Critical Care Associates of Baltimore:

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
Mortality

Estimated Enrollment:	80
Study Start Date:	May 2002
Estimated Study Completion Date:	March 2006

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).

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122018

Sponsors and Collaborators

Pulmonary Critical Care Associates of Baltimore

Abbott

Investigators

Principal Investigator:

Linda F Barr, MD

Pulmonary and Critical Care Assoc. of Baltimore

More Information

Study ID Numbers:	REPORT
Study First Received:	July 14, 2005
Last Updated:	October 19, 2006
ClinicalTrials.gov Identifier:	NCT00122018
Health Authority:	United States: Institutional Review Board

Keywords provided by Pulmonary Critical Care Associates of Baltimore:

Kidney failure
Cardiac Surgery
Fenoldopam
N-acetylcysteine

Study placed in the following topic categories:

Renal Insufficiency
Dopamine
Urologic Diseases
Renal Insufficiency, Chronic
Fenoldopam
Kidney Failure, Chronic

Acetylcysteine
Renal Insufficiency, Acute
Kidney Diseases
Kidney Failure, Acute
N-monoacetylcystine
Kidney Failure

Additional relevant MeSH terms:

Respiratory System Agents
Anti-Infective Agents
Neurotransmitter Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Dopamine Agonists

Antihypertensive Agents
Antiviral Agents
Protective Agents
Pharmacologic Actions
Expectorants
Therapeutic Uses
Free Radical Scavengers
Dopamine Agents
Antidotes

ClinicalTrials.gov processed this record on January 16, 2009