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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Pulmonary Critical Care Associates of Baltimore.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Pulmonary Critical Care Associates of Baltimore
ClinicalTrials.gov Identifier:
NCT00122018
First received: July 14, 2005
Last updated: October 19, 2006
Last verified: October 2006
  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

Resource links provided by NLM:


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
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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

No publications provided

ClinicalTrials.gov Identifier: NCT00122018     History of Changes
Other Study ID Numbers: REPORT
Study First Received: July 14, 2005
Last Updated: October 19, 2006
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:
Renal Insufficiency
Kidney Failure, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Acetylcysteine
N-monoacetylcystine
Fenoldopam
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 22, 2014