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Conditioning With Volatile Anesthetics in Liver Transplantation

Primary Purpose

End-stage Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End-stage Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital Zurich, Division of Anaesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sevoflurane anesthesia

Propofol anesthesia

Arm Description

Outcomes

Primary Outcome Measures

postoperative paek of AST

Secondary Outcome Measures

Full Information

First Posted
May 27, 2009
Last Updated
November 22, 2012
Sponsor
University of Zurich
Collaborators
University Ghent, University Hospital of Sao Paulo, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT00913276
Brief Title
Conditioning With Volatile Anesthetics in Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University Ghent, University Hospital of Sao Paulo, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Liver Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane anesthesia
Arm Type
Other
Arm Title
Propofol anesthesia
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Primary Outcome Measure Information:
Title
postoperative paek of AST
Time Frame
4 y

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice Beck Schimmer, Prof MD
Organizational Affiliation
University Hospital Zurich, Division of Anaesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Anaesthesiology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25769076
Citation
Beck-Schimmer B, Bonvini JM, Schadde E, Dutkowski P, Oberkofler CE, Lesurtel M, DeOliveira ML, Figueira ER, Rocha Filho JA, Auler JO Jr, D'Albuquerque LA, Reyntjens K, Wouters P, Rogiers X, Debaerdemaeker L, Ganter MT, Weber A, Puhan MA, Clavien PA, Breitenstein S. Conditioning With Sevoflurane in Liver Transplantation: Results of a Multicenter Randomized Controlled Trial. Transplantation. 2015 Aug;99(8):1606-12. doi: 10.1097/TP.0000000000000644.
Results Reference
derived

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Conditioning With Volatile Anesthetics in Liver Transplantation

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