Conditioning With Volatile Anesthetics in Liver Transplantation

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: NCT00913276
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : November 27, 2012
University Ghent
University Hospital of Sao Paulo, Brazil
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

The gap between the number of candidates for orthotopic liver transplantation and the availability of suitable liver grafts has led to a rise in deaths on most waiting lists. Strategies applied in many centers to minimize this deficit include living donation or split of a cadaveric organ for two recipients, domino transplantation, and the use of so-called expanded criteria donors. Alternatively, conditioning of an organ would also allow protec-tion of the liver upon ischemia-reperfusion injury, possibly decreasing postoperative liver function and im-proving clinical outcome. The technique of conditioning with the volatile anesthetic sevoflurane is an easily applicable procedure which could be performed in any center worldwide.

Data and experience with sevoflurane attenuating ischemic-reperfusion injury in liver resection lead to the hypothesis of a beneficial effect of volatile anesthetics in liver transplantation. In this randomized controlled trial, patients will be randomly assigned to liver transplantation with propofol anesthesia (propofol group) or sevoflurane conditioning with the volatile anesthetic (sevoflurane group). Primary endpoint is postoperative peak of the transaminase (AST), secondary endpoints are complications, primary liver graft function, ICU and hospital stay. We hypothesis that patients with conditioning have an attenuated increase of transaminases as well as a better outcome.

Condition or disease Intervention/treatment
End-stage Liver Disease Drug: Propofol Drug: Sevoflurane

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2009
Primary Completion Date : August 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sevoflurane anesthesia Drug: Sevoflurane
Propofol anesthesia Drug: Propofol

Primary Outcome Measures :
  1. postoperative paek of AST [ Time Frame: 4 y ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Older than 18 years
  • Patients undergoing liver transplantation
  • Total or partial cadaveric liver transplantation
  • Living related liver transplantation

Exclusion criteria:

  • Patients unable to understand the German or Italian language
  • Patients with known or suspected allergy to propofol, soja or egg
  • Patients with norepinephrine infusion above 15 microg/min
  • Intensive care patients with severe impairment of renal or pulmonary function (e.g. dialysis, hemofiltration, FiO2>0.5)

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): NCT00913276

University Hospital Zurich, Division of Anaesthesiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
University Ghent
University Hospital of Sao Paulo, Brazil
Principal Investigator: Beatrice Beck Schimmer, Prof MD University Hospital Zurich, Division of Anaesthesiology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Zurich Identifier: NCT00913276     History of Changes
Other Study ID Numbers: StV 15-2008
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation