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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

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ClinicalTrials.gov Identifier: NCT01394419
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

July 13, 2011
July 14, 2011
March 6, 2013
September 2010
April 2012   (Final data collection date for primary outcome measure)
Incidence of acute kidney injury [ Time Frame: within 5 days after surgery ]
Same as current
Complete list of historical versions of study NCT01394419 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft
N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft
  • 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
  • Drug: Saline
    Equal volume of normal saline
  • Experimental: NAC group
    N-acetylcysteine
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: Placebo group
    Saline
    Intervention: Drug: Saline
Song JW, Shim JK, Soh S, Jang J, Kwak YL. Double-blinded, randomized controlled trial of N-acetylcysteine for prevention of acute kidney injury in high risk patients undergoing off-pump coronary artery bypass. Nephrology (Carlton). 2015 Feb;20(2):96-102. doi: 10.1111/nep.12361.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
170
April 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01394419
4-2010-0135
Yes
Not Provided
Not Provided
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP