Conditioning With Volatile Anesthetics in Liver Transplantation

November 22, 2012 updated by: University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sevoflurane anesthesia
Drug: Sevoflurane
Other: Propofol anesthesia
Drug: Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative paek of AST
Time Frame: 4 y
4 y

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Ghent
University Hospital of Sao Paulo, Brazil

Investigators

  • Principal Investigator: Beatrice Beck Schimmer, Prof MD, University Hospital Zurich, Division of Anaesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

May 27, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (Estimate)

June 4, 2009

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 22, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StV 15-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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