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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 March 2013 |
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Main ID: |
NCT01394419 |
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Date of registration:
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13/07/2011 |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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September 2010 |
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Target sample size:
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115 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01394419 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft
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Intervention(s)
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Drug: N-acetylcysteine
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Drug: Saline
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Primary Outcome(s)
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Incidence of acute kidney injury
[Time Frame: within 5 days after surgery]
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Secondary ID(s)
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4-2010-0135
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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