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
About this trial
This is an interventional prevention trial for End-stage Liver Disease
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)
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
NCT ID
NCT00913276
First Posted
May 27, 2009
Last Updated
November 22, 2012
Sponsor
University of Zurich
Collaborators
University Ghent, University Hospital of Sao Paulo, Brazil
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
Learn more about this trial
Conditioning With Volatile Anesthetics in Liver Transplantation
We'll reach out to this number within 24 hrs