Conditioning With Volatile Anesthetics in Liver Transplantation

End-stage Liver Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913276
• Other study ID #: StV 15-2008
• Status: Completed
• Phase: N/A
• First received: May 27, 2009
• Last updated: November 22, 2012
• Start date: January 2009
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionBelgium: Institutional Review Board (EudraCT number 2009-015890-11)Sao Paulo: Institutional Review Board ok.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• End-stage Liver Disease
• Liver Diseases

Intervention

Drug:
• Propofol

• Sevoflurane

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Anaesthesiology	Zurich	ZH

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	University Ghent, University Hospital of Sao Paulo, Brazil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative paek of AST		4 y	Yes