NCT00526695

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 18, 2008

Status Verified

July 1, 2008

Enrollment Period

3.9 years

First QC Date

August 27, 2007

Last Update Submit

July 17, 2008

Conditions

Ischemia/Reperfusion Injury

Keywords

Ischemia/ReperfusionOrgan ProtectionAnesthetics

Outcome Measures

Primary Outcomes (1)

  • marker expression on blood cells

    December 2008

Interventions

Sevoflurane (Preconditioning)DRUG

Inhalation of sub-anesthetic doses of sevoflurane

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoker
  • No asthma
  • NPO
  • Volunteer

You may not qualify if:

  • Female
  • Chronic medication
  • Asthma
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, Switzerland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19762739DERIVED

MeSH Terms

Conditions

Reperfusion InjuryIschemia

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Michael Zaugg, PD Dr. med.

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

  • Michael Zaugg, PD Dr. med.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

01 Studienregister MasterAdmins

CONTACT

+41 (0)44 255 11 11

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2007

First Posted

September 10, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 18, 2008

Record last verified: 2008-07

Locations

CH(1)