This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

This study has been completed.
Information provided by:
Minneapolis Veterans Affairs Medical Center Identifier:
First received: September 13, 2005
Last updated: September 18, 2007
Last verified: September 2007
The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery

Condition Intervention Phase
Kidney Failure Drug: N-Acetylcysteine Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 102
Study Start Date: April 2003
Study Completion Date: November 2006
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


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
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 identifier: 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 Identifier (NCT Number): Identifier: NCT00211653     History of Changes
Other Study ID Numbers: 3212-B
Study First Received: September 13, 2005
Last Updated: September 18, 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
Antidotes processed this record on August 18, 2017