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. Identifier: NCT00211653
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 19, 2007
Information provided by:
Minneapolis Veterans Affairs Medical Center

September 13, 2005
September 21, 2005
September 19, 2007
April 2003
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Rise in creatinine above baseline [ Time Frame: 7 days postoperatively ]
Creatinine increase > 0.5 mg/dl above baseline 1 week after cardiac surgery
Complete list of historical versions of study NCT00211653 on Archive Site
  • Creatinine increase >25% or =/> 0.5 mg/dl above baseline [ Time Frame: Postoperative days 5, 7 and 30 ]
  • Length of stay in the ICU and the hospital
  • Operative mortality [ Time Frame: 30-day ]
Creatinine increase > 0.5 mg/dl above baseline 1 month after cardiac surgery
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Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery
Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure
The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery

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

Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Kidney Failure
Drug: N-Acetylcysteine
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Adabag AS, Ishani A, Koneswaran S, Johnson DJ, Kelly RF, Ward HB, McFalls EO, Bloomfield HE, Chandrashekhar Y. Utility of N-acetylcysteine to prevent acute kidney injury after cardiac surgery: a randomized controlled trial. Am Heart J. 2008 Jun;155(6):1143-9. doi: 10.1016/j.ahj.2008.01.013. Epub 2008 Mar 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2006
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Minneapolis Veterans Affairs Medical Center
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Principal Investigator: Selcuk Adabag, MD Minneapolis Veterans Affairs Medical Center
Minneapolis Veterans Affairs Medical Center
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP