End-stage Liver DiseaseNCT00913276
Conditioning With Volatile Anesthetics in Liver Transplantation
A study testing Propofol and Sevoflurane in people with End-stage Liver Disease, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Liver Disease
- What is being tested?
- Propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years
- Patients undergoing liver transplantation
- Total or partial cadaveric liver transplantation
- Living related liver transplantation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Anaesthesiology
Zurich, Canton of Zurich, 8091
About this study
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
- Being tested
- Propofol, Sevoflurane
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
SevofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane anesthesia | Other | Not described Receives: Drug: Sevoflurane |
| Propofol anesthesia | Other | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative paek of AST
Measured: 4 y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Beatrice Beck Schimmer, Prof MD, Principal investigator, University Hospital Zurich, Division of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913276
- Sponsor's protocol ID
- StV 15-2008
- Status last verified
- Nov 2012
- First submitted
- 27 May 2009
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25769076
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conditioning With Volatile Anesthetics in Liver Transplantation
- ClinicalTrials.gov ID
- NCT00913276
- Acronym / sponsor ID
- StV 15-2008
- Conditions
- End-stage Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Ghent, University of Sao Paulo
- Study start
- Jan 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane anesthesia | Other | Drug: Sevoflurane |
| Propofol anesthesia | Other | Drug: Propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years
- Patients undergoing liver transplantation
- Total or partial cadaveric liver transplantation
- Living related liver transplantation
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol | Drug | Propofol anesthesia |
| Sevoflurane | Drug | Sevoflurane anesthesia |
Primary outcome
postoperative paek of AST
Time frame: 4 y
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Derived from this study: PubMed 25769076Beck-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatrice Beck Schimmer, Prof MD principal investigator
University Hospital Zurich, Division of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with End-stage Liver Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative paek of AST (time frame: 4 y). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.