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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394419
• Other study ID #: 4-2010-0135
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2011
• Last updated: March 4, 2013
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: March 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• N-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
• Saline
Equal volume of normal saline

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute kidney injury		within 5 days after surgery	No