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

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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.

Resource links provided by NLM:

MedlinePlus related topics: Critical Care Health Facilities Heart Surgery Kidney Failure

Drug Information available for: Acetylcysteine Fenoldopam Fenoldopam mesylate

U.S. FDA Resources

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

Primary Outcome Measures:

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 Outcome Measures:

Days to post-operative creatinine clearance nadir [ Time Frame: 14 day ]
Intraoperative and post-operative pressor use (pressor-hours) [ Time Frame: 48 hour ]
Hospital costs [ Time Frame: 30-day ]
Mortality [ Time Frame: 30-day ]


Estimated Enrollment:	80
Study Start Date:	May 2002
Study Completion Date:	March 2006
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NAC N-acetylcysteine started day prior to surgery, continued through night of surgery	Drug: N-acetylcysteine Other Name: Mucomyst
Experimental: fenoldopam fenoldopam started at surgery continued for 24 hours	Drug: fenoldopam Other Name: Corlopam
Experimental: NAC and fenoldopam Both N-acetylcysteine and fenoldopam as above	Drug: N-acetylcysteine Other Name: Mucomyst Drug: fenoldopam Other Name: Corlopam
Placebo Comparator: Control Placebo

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Linda F. Barr, M.D.

Abbott

Investigators


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

More Information

Publications:

Barr LF, Kolodner K. N-acetylcysteine and fenoldopam protect the renal function of patients with chronic renal insufficiency undergoing cardiac surgery. Crit Care Med. 2008 May;36(5):1427-35. doi: 10.1097/CCM.0b013e31816f48ba.


Responsible Party:	Linda F. Barr, M.D., Primary Investigator, Pulmonary Critical Care Associates of Baltimore
ClinicalTrials.gov Identifier:	NCT00122018 History of Changes
Other Study ID Numbers:	REPORT
Study First Received:	July 14, 2005
Last Updated:	November 6, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Pulmonary Critical Care Associates of Baltimore:


Kidney failure Cardiac Surgery Fenoldopam N-acetylcysteine

Additional relevant MeSH terms:


Acute Kidney Injury Kidney Failure, Chronic Renal Insufficiency Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Acetylcysteine Fenoldopam N-monoacetylcystine Anti-Infective Agents Antidotes Antihypertensive Agents Antioxidants Antiviral Agents	Cardiovascular Agents Dopamine Agents Dopamine Agonists Expectorants Free Radical Scavengers Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Respiratory System Agents Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on February 26, 2015