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Conditioning With Volatile Anesthetics in Liver Transplantation

This study has been completed.
Sponsor:
Collaborators:
University Ghent
University Hospital of Sao Paulo, Brazil
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00913276
First received: May 27, 2009
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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 Intervention
End-stage Liver Disease
Drug: Propofol
Drug: Sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • postoperative paek of AST [ Time Frame: 4 y ] [ Designated as safety issue: Yes ]

Enrollment: 98
Study Start Date: January 2009
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sevoflurane anesthesia Drug: Sevoflurane
Propofol anesthesia Drug: Propofol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913276

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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00913276     History of Changes
Other Study ID Numbers: StV 15-2008
Study First Received: May 27, 2009
Last Updated: November 22, 2012
Health Authority: Switzerland: Ethikkommission
Belgium: Institutional Review Board (EudraCT number 2009-015890-11)
Sao Paulo: Institutional Review Board ok.

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

ClinicalTrials.gov processed this record on November 20, 2014