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Conditioning With Volatile Anesthetics in Liver Transplantation

NCT ID: NCT00913276

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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End-stage Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sevoflurane anesthesia

Group Type OTHER

Sevoflurane

Intervention Type DRUG

Propofol anesthesia

Group Type OTHER

Propofol

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

Sevoflurane

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role collaborator

University Hospital of Sao Paulo, Brazil

UNKNOWN

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beatrice Beck Schimmer, Prof MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Anaesthesiology

Locations

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University Hospital Zurich, Division of Anaesthesiology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 25769076 (View on PubMed)

Other Identifiers

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StV 15-2008

Identifier Type: -

Identifier Source: org_study_id