Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: July 13, 2011
Last updated: March 4, 2013
Last verified: March 2013
N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.

Condition Intervention Phase
Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft
Drug: N-acetylcysteine
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of acute kidney injury [ Time Frame: within 5 days after surgery ]

Enrollment: 115
Study Start Date: September 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NAC group
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
Placebo Comparator: Placebo group
Drug: Saline
Equal volume of normal saline


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01394419

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yonsei University Identifier: NCT01394419     History of Changes
Other Study ID Numbers: 4-2010-0135
Study First Received: July 13, 2011
Last Updated: March 4, 2013

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes processed this record on May 25, 2017