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Clinical Trials/NCT01394419
NCT01394419
Completed
Phase 4

Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft

Yonsei University1 site in 1 country115 target enrollmentSeptember 2010

Overview

Phase
Phase 4
Intervention
N-acetylcysteine
Conditions
Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft
Sponsor
Yonsei University
Enrollment
115
Locations
1
Primary Endpoint
Incidence of acute kidney injury
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
April 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing off-pump coronary artery bypass surgery and meets more than one of the following criteria;
  • preoperative serum creatinine \> 1.4 mg/dl
  • Age \> 70 years
  • Diabetes mellitus
  • left ventricular ejection fraction \< 35 % or congestive heart failure (NYHA III or IV)
  • emergency surgery or re-operation

Exclusion Criteria

  • preoperative acute renal failure, patients on dialysis, use of N-acetylcystein within 5 days of surgery, history of hypersensitivity to N-acetylcystein

Arms & Interventions

NAC group

N-acetylcysteine

Intervention: N-acetylcysteine

Placebo group

Saline

Intervention: Saline

Outcomes

Primary Outcomes

Incidence of acute kidney injury

Time Frame: within 5 days after surgery

Study Sites (1)

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