- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394419
Effect of N-acetylcysteine on Prevention of Acute Kidney Injury in High Risk Patients Undergoing Off-pump Coronary Artery Bypass Graft
March 4, 2013 updated by: Yonsei University
N-acetylcysteine may prevent acute kidney injury in high risk patients undergoing off-pump coronary artery bypass graft.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
115
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 120-752
- Severance Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NAC group
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
|
Equal volume of normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of acute kidney injury
Time Frame: within 5 days after surgery
|
within 5 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
July 13, 2011
First Submitted That Met QC Criteria
July 13, 2011
First Posted (Estimate)
July 14, 2011
Study Record Updates
Last Update Posted (Estimate)
March 6, 2013
Last Update Submitted That Met QC Criteria
March 4, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Wounds and Injuries
- Acute Kidney Injury
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- 4-2010-0135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Acute Kidney Injury After Off-pump Coronary Artery Bypass Graft
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Peking University Third HospitalNot yet recruitingCoronary Artery Bypass, Off-PumpChina
-
Peking University Third HospitalRecruitingCoronary Artery Bypass, Off-PumpChina
-
General Hospital of Ningxia Medical UniversityUnknownCoronary Artery Bypass, Off-PumpChina
-
University Medical Center GroningenTerminated
-
Pluromed, Inc.UnknownOff Pump Coronary Artery Bypass SurgeryGermany
-
University Hospital, GhentCAS Medical Systems, Inc.; Belgian Foundation for Cardiac SurgeryCompletedElective Off-pump Coronary Artery Bypass GraftingBelgium
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Samsung Medical CenterCompletedOff Pump Coronary Artery Bypass GraftKorea, Republic of
-
Assiut UniversityUnknownAcute Normovolemic Hemodilution | Off-Pump Coronary Artery Bypass SurgeryEgypt
-
Chinese Academy of Medical Sciences, Fuwai HospitalCompletedOff Pump Coronary Artery Bypass SurgeryChina
-
Yonsei UniversityCompletedOff Pump Coronary Artery Bypass SurgeryKorea, Republic of
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