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

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ClinicalTrials.gov Identifier: NCT00122018
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : November 7, 2014
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Linda F. Barr, M.D., Pulmonary Critical Care Associates of Baltimore

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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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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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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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122018


Sponsors and Collaborators
Linda F. Barr, M.D.
Abbott
Investigators
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Principal Investigator: Linda F Barr, MD Pulmonary and Critical Care Assoc. of Baltimore
More Information
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Publications of Results:

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Responsible Party: Linda F. Barr, M.D., Primary Investigator, Pulmonary Critical Care Associates of Baltimore
ClinicalTrials.gov Identifier: NCT00122018    
Other Study ID Numbers: REPORT
First Posted: July 21, 2005    Key Record Dates
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:
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Renal Insufficiency
Kidney Failure, Chronic
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Acetylcysteine
Fenoldopam
N-monoacetylcystine
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