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Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00211653
First received: September 13, 2005
Last updated: September 18, 2007
Last verified: September 2007
History of Changes

September 13, 2005
September 18, 2007
April 2003
Not Provided
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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Kidney Failure
Drug: N-Acetylcysteine
Not Provided
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. Epub 2008 Mar 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
November 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211653
3212-B
No
Not Provided
Minneapolis Veterans Affairs Medical Center
Not Provided
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