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Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00211653
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 19, 2007
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Study Description
Brief Summary:
The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery

Condition or disease Intervention/treatment Phase
Kidney Failure Drug: N-Acetylcysteine Phase 1 Phase 2

Detailed Description:

Postoperative renal dysfunction is a predictor of significant morbidity and mortality among patients undergoing cardiac surgery. The mortality associated with coronary artery by-pass surgery increases from 2% to almost 19% in patients with renal failure and approaches 60% in patients who require hemodialysis. Patients with preoperative renal dysfunction referred for coronary artery by pass surgery have an extraordinarily high risk of requiring postoperative dialysis. For example, among those patients with preoperative creatinine >2.5 mg/dL, almost 50% require hemodialysis.

Comparison: N-Acetylcysteine is superior to placebo in preventing renal failure after cardiac surgery

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure
Study Start Date : April 2003
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Rise in creatinine above baseline [ Time Frame: 7 days postoperatively ]

Secondary Outcome Measures :
  1. Creatinine increase >25% or =/> 0.5 mg/dl above baseline [ Time Frame: Postoperative days 5, 7 and 30 ]
  2. Length of stay in the ICU and the hospital
  3. Operative mortality [ Time Frame: 30-day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pts with baseline chronic kidney disease (eGFR<60 ml/min/1.73m2)undergoing cardiac surgery

Exclusion Criteria:

  • Patients on hemodialysis preoperatively
  • IV contrast within 4 days prior to surgery
  • Urgent/emergent surgery
  • History of renal transplantation
Contacts and Locations

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): NCT00211653

United States, Minnesota
Veterans Affairs Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Principal Investigator: Selcuk Adabag, MD Minneapolis Veterans Affairs Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00211653     History of Changes
Other Study ID Numbers: 3212-B
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 19, 2007
Last Verified: September 2007

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Kidney failure
Thoracic surgery

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs