HepatectomyNCT00518908
Organ Protection With Sevoflurane Postconditioning
A study testing Sevoflurane in people with Hepatectomy, run by University of Zurich at 1 site in Switzerland.
Trial summary
Organ protection, volatile anesthetics, postconditioning, hepatic surgery Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatectomy
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Sep 2010
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years
- patients undergoing liver resection (benign or malignant tumors)
Who cannot join
- non-german speakers
- 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: Postconditioning
Organ protection, volatile anesthetics, postconditioning, hepatic surgery
Read the detailed description
This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.
- Conditions
- Hepatectomy
- Being tested
- Sevoflurane
- Keywords
- Ischemia reperfusion injury, Organ protection
- 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
3.2 Vol % for postconditioning
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Experimental | Sevoflurane for pharmacological postconditioning Receives: Drug: Sevoflurane |
| Propofol | Experimental | Anesthesia maintenance with propofol instead of Sevoflurane postconditioning Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver transaminase AST
Peak value
Measured: Postoperative phase until discharge
Secondary outcomes (5)
ALT peak value
Measured: Postoperative phase until discharge
Course of transaminases
Measured: From the day before surgery, to 6 hours after surgery, up to postoperative day 7
Postoperative complications
Measured: Postoperative phase until discharge
Length of hospital stay
Measured: Postoperative phase until discharge
Need for prolonged intensive care unit stay (>24 hours)
Measured: Postoperative phase until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startJan 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
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
- NCT00518908
- Sponsor's protocol ID
- StV 34-2007
- Status last verified
- Jul 2011
- First submitted
- 20 Aug 2007
- Last updated
- 19 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. 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: Postconditioning
- ClinicalTrials.gov ID
- NCT00518908
- Acronym / sponsor ID
- StV 34-2007
- Conditions
- Hepatectomy
- Keywords
- Ischemia reperfusion injury, Organ protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 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.
Organ protection, volatile anesthetics, postconditioning, hepatic surgery
Detailed description
This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury in the liver with sevoflurane postconditioning upon reperfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Experimental | Drug: SevofluraneSevoflurane for pharmacological postconditioning |
| Propofol | Experimental | Drug: SevofluraneAnesthesia maintenance with propofol instead of Sevoflurane postconditioning |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than 18 years
- patients undergoing liver resection (benign or malignant tumors)
Key exclusion criteria (4 listed)
- non-german speakers
- 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 |
|---|---|---|
| Sevoflurane3.2 Vol % for postconditioning | Drug | Propofol, Sevoflurane |
Primary outcome
Liver transaminase AST
Time frame: Postoperative phase until discharge
Peak value
5 secondary outcomes
ALT peak value
Time frame: Postoperative phase until discharge
Course of transaminases
Time frame: From the day before surgery, to 6 hours after surgery, up to postoperative day 7
Postoperative complications
Time frame: Postoperative phase until discharge
Length of hospital stay
Time frame: Postoperative phase until discharge
Need for prolonged intensive care unit stay (>24 hours)
Time frame: Postoperative phase until discharge
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 19 Jul 2011.
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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 Hepatectomy, 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 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 19 Jul 2011. 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?
Liver transaminase AST (time frame: Postoperative phase until discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2011.