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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.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01394419
First received: July 13, 2011
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Incidence of acute kidney injury [ Time Frame: within 5 days after surgery ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394419

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01394419     History of Changes
Other Study ID Numbers: 4-2010-0135
Study First Received: July 13, 2011
Last Updated: March 4, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 23, 2013