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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01394419

Enrollment

115

Registered

2011-07-14

Start date

2010-09-30

Completion date

2012-04-30

Last updated

2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Interventions

DRUGN-acetylcysteine

N-acetylcysteine 150 mg/kg bolus over 15 min after induction of anesthesia, followed by an infusion of 150 mg/kg/day for 24 hrs

DRUGSaline

Equal volume of normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of acute kidney injury	within 5 days after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026