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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Kidney Failure, Acute; Kidney Failure, Chronic; Cardiac Surgical Procedures	Drug: N-acetylcysteine; Drug: fenoldopam	Phase 2

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Double
Primary Purpose:	Prevention
Official Title:	N-acetylcysteine and Fenoldopam Protect the Renal Function of Patients With Chronic Renal Insufficiency Undergoing Cardiac Surgery.
Study Start Date :	May 2002
Actual Primary Completion Date :	March 2006
Actual Study Completion Date :	March 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Length of post-operative hospital stay [ Time Frame: 30-day ]
2. Length of post-operative critical care stay [ Time Frame: 30-day ]
3. Creatinine clearance post-operative days 3, 14, and nadir [ Time Frame: 14 day ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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
First Posted:	July 21, 2005
Last Update Posted:	November 7, 2014
Last Verified:	November 2014

Keywords provided by Linda F. Barr, M.D., Pulmonary Critical Care Associates of Baltimore:

Kidney failure; Cardiac Surgery; Fenoldopam; N-acetylcysteine

Additional relevant MeSH terms:

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