Conditioning With Volatile Anesthetics in Liver Transplantation

NCT00913276 | Completed DMC

• 1 other identifier: StV 15-2008
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Liver Disease

Outcome Measures

Primary Outcomes (1)

• postoperative paek of AST

  4 y

Study Arms (2)

Sevoflurane anesthesia

OTHER

Drug: Sevoflurane

Propofol anesthesia

OTHER

Drug: Propofol

Interventions

Propofol DRUG

Propofol anesthesia

Sevoflurane DRUG

Sevoflurane anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years
• Patients undergoing liver transplantation
• Total or partial cadaveric liver transplantation
• Living related liver transplantation

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• University Ghent: collaborator
• University of Sao Paulo: collaborator

Study Sites (1)

University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 25769076 DERIVED

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Beatrice Beck Schimmer, Prof MD

  University Hospital Zurich, Division of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: June 4, 2009
• Study Start: January 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

CH (1)