Clinical trial NCT00913276: Conditioning With Volatile Anesthetics in Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Liver Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University Ghent
name: University Hospital of Sao Paulo, Brazil
First posted: 2009-06-04
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: postoperative paek of AST
timeFrame: 4 y
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Anaesthesiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Anaesthesiology
name: Beatrice Beck Schimmer, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
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.