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Conditioning With Volatile Anesthetics in Liver Transplantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00913276
Enrollment
98
Registered
2009-06-04
Start date
2009-01-31
Completion date
2012-10-31
Last updated
2012-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Liver Disease

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.

Interventions

DRUGPropofol
DRUGSevoflurane

Sponsors

University Ghent
CollaboratorOTHER
University of Sao Paulo
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
postoperative paek of AST4 y

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026