- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211653
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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rise in creatinine above baseline
Time Frame: 7 days postoperatively
|
7 days postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Creatinine increase >25% or =/> 0.5 mg/dl above baseline
Time Frame: Postoperative days 5, 7 and 30
|
Postoperative days 5, 7 and 30
|
Length of stay in the ICU and the hospital
|
|
Operative mortality
Time Frame: 30-day
|
30-day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Selcuk Adabag, MD, Minneapolis Veterans Affairs Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- 3212-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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