Reperfusion InjuryNCT00516711
Role of Volatile Anesthetics for Hepatic Protection
A study testing Sevoflurane in people with Reperfusion Injury, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory mediators). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Reperfusion Injury
- What is being tested?
- Sevoflurane
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2006to Dec 2007
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older than 18 years of age
- Patients undergoing liver resection (benign or malignant tumors)
Who cannot join
- Laparoscopic liver resection coagulopathy (platelets < 50,000/ml, Quick < 50%)
- Liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion
This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory mediators).
Read the detailed description
Organ protection; preconditioning; volatile anesthetics; ischemia reperfusion
- Conditions
- Reperfusion Injury
- Being tested
- Sevoflurane
- Keywords
- Surgery with Pringle maneuver needed for liver resection
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionDec 2007
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 Reperfusion InjuryStudies 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)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516711
- Sponsor's protocol ID
- StV 5-2006
- Status last verified
- Aug 2007
- First submitted
- 14 Aug 2007
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Beck-Schimmer B, Breitenstein S, Urech S, De Conno E, Wittlinger M, Puhan M, Jochum W, Spahn DR, Graf R, Clavien PA. A randomized controlled trial on pharmacological preconditioning in liver surgery using a volatile anesthetic. Ann Surg. 2008 Dec;248(6):909-18. doi: 10.1097/SLA.0b013e31818f3dda.
PubMed 19092335
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Volatile Anesthetics for Hepatic Protection in Ischemia-reperfusion
- ClinicalTrials.gov ID
- NCT00516711
- Acronym / sponsor ID
- StV 5-2006
- Conditions
- Reperfusion Injury
- Keywords
- Surgery with Pringle maneuver needed for liver resection
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Aug 2007 (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.
This study aims to evaluate the attenuation of ischemic-reperfusion injury in the liver after sevoflurane preconditioning. In the presence of sevoflurane, an attenuation of liver injury is hypothesized (diminished increase of liver enzymes, reduced production of inflammatory mediators).
Detailed description
Organ protection; preconditioning; volatile anesthetics; ischemia reperfusion
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years of age
- Patients undergoing liver resection (benign or malignant tumors)
Key exclusion criteria (2 listed)
- Laparoscopic liver resection coagulopathy (platelets < 50,000/ml, Quick < 50%)
- Liver cirrhosis
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 |
|---|---|---|
| Sevoflurane | Drug | – |
Primary outcome
Blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT)
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 15 Sep 2010.
- Derived from this study: PubMed 19092335Beck-Schimmer B, Breitenstein S, Urech S, De Conno E, Wittlinger M, Puhan M, Jochum W, Spahn DR, Graf R, Clavien PA. A randomized controlled trial on pharmacological preconditioning in liver surgery using a volatile anesthetic. Ann Surg. 2008 Dec;248(6):909-18. doi: 10.1097/SLA.0b013e31818f3dda.
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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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane in people with Reperfusion Injury, 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 2 inclusion and 2 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 15 Sep 2010. 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?
Blood levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT). 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 NCT00516711, 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 15 Sep 2010.