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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Linda F. Barr, M.D., Pulmonary Critical Care Associates of Baltimore
ClinicalTrials.gov Identifier:
NCT00122018
First received: July 14, 2005
Last updated: November 6, 2014
Last verified: November 2014
  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:


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   (Adult, Senior)
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:
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:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
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

ClinicalTrials.gov processed this record on December 02, 2016