Back to resultsEffects of N-acetylcysteine on Pulmonary Function in High-risk Patients Undergoing Off-pump Coronary Bypass Surgery
Primary Purpose
Coronary Artery Occlusion
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
N-acetylcysteine, saline
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Occlusion
Eligibility Criteria
Inclusion Criteria:
- Adult patients with Euroscore ≥ 5
Exclusion Criteria:
- Patients in need of emergency surgery,acute renal failure patients, kidney transplanted patients, patients injected with NAC 5days before planned surgery
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
N-acetylcysteine , saline
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01021163
Brief Title
Effects of N-acetylcysteine on Pulmonary Function in High-risk Patients Undergoing Off-pump Coronary Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to study the effects of N-acetylcysteine on pulmonary function in high-risk patients undergoing off-pump coronary bypass surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine , saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine, saline
Intervention Description
Inject 100 mg/kg of N-acetylcysteine or the equivalent amount of saline for 15 minutes before the skin incision, then continuously inject 40 mg/kg/day of N-acetylcysteine or the equivalent amount of saline during the next 24 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients with Euroscore ≥ 5
Exclusion Criteria:
Patients in need of emergency surgery,acute renal failure patients, kidney transplanted patients, patients injected with NAC 5days before planned surgery
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of N-acetylcysteine on Pulmonary Function in High-risk Patients Undergoing Off-pump Coronary Bypass Surgery
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