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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft

Treatments: Drug: Saline; Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01394419

4-2010-0135

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 2 patient groups, including a placebo group

NAC group

Experimental group

Description:

N-acetylcysteine

Treatment:

Drug: N-acetylcysteine

Placebo group

Placebo Comparator group

Description:

Saline

Treatment:

Drug: Saline