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Effects of N-acetylcysteine on Pulmonary Function in High-risk Patients Undergoing Off-pump Coronary Bypass Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021163
First Posted: November 26, 2009
Last Update Posted: November 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
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.

Condition Intervention Phase
Coronary Artery Occlusion Drug: N-acetylcysteine, saline Phase 4

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Enrollment: 48
Arms Assigned Interventions
Placebo Comparator: N-acetylcysteine , saline Drug: N-acetylcysteine, saline
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021163


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

Responsible Party: Young Lan Kwak / Professor, Anesthesiology and Pain Medicine
ClinicalTrials.gov Identifier: NCT01021163     History of Changes
Other Study ID Numbers: 4-2007-0236
First Submitted: November 25, 2009
First Posted: November 26, 2009
Last Update Posted: November 26, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Coronary Occlusion
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes