Ischemia/Reperfusion InjuryPhase 4NCT00526695
Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion
A Phase 4 study testing Sevoflurane (Preconditioning) in people with Ischemia/Reperfusion Injury, run by University of Zurich at 1 site in Switzerland.
Trial summary
Sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion injury. Study hypothesis: The volatile anesthetic sevoflurane at subanesthetic concentrations achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory markers in the circulation Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ischemia/Reperfusion Injury
- What is being tested?
- Sevoflurane (Preconditioning)
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 4
- 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 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker
- No asthma
- NPO
- Volunteer
Who cannot join
- Female
- Chronic medication
- Asthma
- Smoking
Trial locations and contacts
1 site in 1 country.
01 Studienregister MasterAdmins contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Zurich
Zurich
Michael Zaugg, MD, michael.zaugg@usz.ch
Michael Zaugg, MD
About this study
Official title: Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion, Leukocyte/Thrombocyte Activation, and Endothelial Function After Tourniquet-Induced Ischemia/Reperfusion Injury in the Forearm of Volunteers
Sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion injury.
Study hypothesis: The volatile anesthetic sevoflurane at subanesthetic concentrations achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory markers in the circulation
Read the detailed description
Healthy volunteers are included in the study to investigate endothelial function and platelet activation after preconditioning by sevoflurane in subanesthetic concentrations.
Forearm perfusion, endothelial function and leukocyte/thrombocyte activation after tourniquet-induced ischemia/reperfusion injury of the forearm are measured using healthy volunteers in a cross-over design.
- Conditions
- Ischemia/Reperfusion Injury
- Being tested
- Sevoflurane (Preconditioning)
- Keywords
- Ischemia/Reperfusion, Organ Protection, Anesthetics
- Medical subject headings
- Reperfusion Injury, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane (Preconditioning)Drug
Inhalation of sub-anesthetic doses of sevoflurane
What is being measured
The primary outcome is the main question the study is designed to answer.
marker expression on blood cells
Measured: December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJan 2005
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
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 Ischemia/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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Michael Zaugg, PD Dr. med., Principal investigator, UniversitaetsSpital ZuerichMichael Zaugg, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526695
- Sponsor's protocol ID
- 17-2005
- Status last verified
- Jul 2008
- First submitted
- 27 Aug 2007
- Last updated
- 18 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lucchinetti E, Zeisberger SM, Baruscotti I, Wacker J, Feng J, Zaugg K, Dubey R, Zisch AH, Zaugg M. Stem cell-like human endothelial progenitors show enhanced colony-forming capacity after brief sevoflurane exposure: preconditioning of angiogenic cells by volatile anesthetics. Anesth Analg. 2009 Oct;109(4):1117-26. doi: 10.1213/ANE.0b013e3181b5a277.
PubMed 19762739
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sevoflurane in Subanesthetic Concentrations on the Forearm Perfusion, Leukocyte/Thrombocyte Activation, and Endothelial Function After Tourniquet-Induced Ischemia/Reperfusion Injury in the Forearm of Volunteers
- ClinicalTrials.gov ID
- NCT00526695
- Acronym / sponsor ID
- 17-2005
- Conditions
- Ischemia/Reperfusion Injury
- Keywords
- Ischemia/Reperfusion, Organ Protection, Anesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 10 Sep 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.
Sevoflurane preconditioning and cardiovascular protection against ischemia/reperfusion injury.
Study hypothesis: The volatile anesthetic sevoflurane at subanesthetic concentrations achieves endothelial protection against ischemia/reperfusion injury and reduces inflammatory markers in the circulation
Detailed description
Healthy volunteers are included in the study to investigate endothelial function and platelet activation after preconditioning by sevoflurane in subanesthetic concentrations.
Forearm perfusion, endothelial function and leukocyte/thrombocyte activation after tourniquet-induced ischemia/reperfusion injury of the forearm are measured using healthy volunteers in a cross-over design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoker
- No asthma
- NPO
- Volunteer
Key exclusion criteria (4 listed)
- Female
- Chronic medication
- Asthma
- Smoking
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 (Preconditioning)Inhalation of sub-anesthetic doses of sevoflurane | Drug | – |
Primary outcome
marker expression on blood cells
Time frame: December 2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2008.
- Derived from this study: PubMed 19762739Lucchinetti E, Zeisberger SM, Baruscotti I, Wacker J, Feng J, Zaugg K, Dubey R, Zisch AH, Zaugg M. Stem cell-like human endothelial progenitors show enhanced colony-forming capacity after brief sevoflurane exposure: preconditioning of angiogenic cells by volatile anesthetics. Anesth Analg. 2009 Oct;109(4):1117-26. doi: 10.1213/ANE.0b013e3181b5a277.
Related trials for Ischemia/Reperfusion Injury
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
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 contact
Michael Zaugg, PD Dr. med. principal investigator
UniversitaetsSpital Zuerich
Michael Zaugg, PD Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane (Preconditioning) in people with Ischemia/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 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: status not confirmed, as of the sponsor's last update on 18 Jul 2008. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 01 Studienregister MasterAdmins (+41 (0)44 255 11 11), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marker expression on blood cells (time frame: December 2008). 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 NCT00526695, 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 18 Jul 2008.