Conditioning With Volatile Anesthetics in Liver Transplantation
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Purpose
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.
| Condition | Intervention |
|---|---|
|
End-stage Liver Disease |
Drug: Propofol Drug: Sevoflurane |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
- postoperative paek of AST [ Time Frame: 4 y ] [ Designated as safety issue: Yes ]
| Enrollment: | 98 |
| Study Start Date: | January 2009 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Sevoflurane anesthesia | Drug: Sevoflurane |
| Propofol anesthesia | Drug: Propofol |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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)
Contacts and Locations| Switzerland | |
| University Hospital Zurich, Division of Anaesthesiology | |
| Zurich, ZH, Switzerland, 8091 | |
| Principal Investigator: | Beatrice Beck Schimmer, Prof MD | University Hospital Zurich, Division of Anaesthesiology |
More Information
No publications provided
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT00913276 History of Changes |
| Other Study ID Numbers: | StV 15-2008 |
| Study First Received: | May 27, 2009 |
| Last Updated: | November 22, 2012 |
| Health Authority: | Switzerland: Ethikkommission Belgium: Institutional Review Board (EudraCT number 2009-015890-11) Sao Paulo: Institutional Review Board ok. |
Additional relevant MeSH terms:
|
Liver Diseases End Stage Liver Disease Digestive System Diseases Liver Failure Hepatic Insufficiency Propofol Sevoflurane Anesthetics, Intravenous Anesthetics, General Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on May 23, 2013