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Organ Protection With Sevoflurane Postconditioning After Cardiac Surgery With Cardiopulmonary Bypass

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. Identifier: NCT00924222
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Organ protection, volatile anesthetics, postconditioning.

Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood.

Condition or disease Intervention/treatment Phase
Cardiac On-pump Surgery Drug: Sevoflurane Drug: Propofol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sevoflurane Drug: Sevoflurane
Sedation with sevoflurane

Drug: Propofol
Sedation on intensive care unit with propofol

Experimental: Propofol Drug: Sevoflurane
Sedation with sevoflurane

Drug: Propofol
Sedation on intensive care unit with propofol

Primary Outcome Measures :
  1. Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T) [ Time Frame: Start and end of ICU stay ]

Secondary Outcome Measures :
  1. Oxygenation index, postoperative pulmonary complications, ICU stay (days), length of hospitalisation [ Time Frame: Start with surgery until end of hospitalisation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • CABG and/or heart valve surgery with CPB
  • Ejection fraction (EF) = 30%
  • Canadian Cardiovascular Society (CCS) classification = 3
  • Ages 18 to 90 years old

Exclusion criteria:

  • Pulmonary disease: forced expiratory volume in one second (FEV1) < 80%; FEV1/forced vital capacity (FVC) < 70%
  • Renal disease and/ or creatinine-clearance < 60 ml/min
  • Previous cardiac surgery
  • Emergency procedures
  • Postoperative intra aortic balloon pump (IABP) requirement
  • Myocardial infarction < 7d
  • Steroid treatment
  • Insulin-dependent diabetes
  • Pregnancy

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 identifier (NCT number): NCT00924222

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Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
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Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Zurich Identifier: NCT00924222     History of Changes
Other Study ID Numbers: IFA-5-2007
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation