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

Phase 4

Completed

• Conditions: Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft
• Interventions: Drug: N-acetylcysteine; Drug: Saline

• Registration Number: NCT01394419
• Lead Sponsor: Yonsei University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAC group	N-acetylcysteine	N-acetylcysteine
Placebo group	Saline	Saline

Primary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury	within 5 days after surgery

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of