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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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211653

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

No publications provided by Minneapolis Veterans Affairs Medical Center

Additional 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
Study First Received: September 13, 2005
Last Updated: September 18, 2007
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 19, 2013