NCT02038062

Brief Summary

Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

January 14, 2014

Last Update Submit

November 27, 2016

Conditions

Tissue Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

  • Decrease of tissue oxygen saturation below 95 % of baseline

    Decrease of tissue oxygen saturation below 95 % of baseline

    4 hours

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Sevoflurane Preconditioning

Procedure: Sevoflurane preconditioning

No Sevoflurane

NO INTERVENTION

No Sevoflurane Preconditioning

Interventions

Sevoflurane preconditioningPROCEDURE

Preconditioning by transient application of sevoflurane

Sevoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (1)

  • Fudickar A, Kunath S, Voss D, Siggelkow M, Cavus E, Steinfath M, Bein B. Effect of ischemic and pharmacological preconditioning of lower limb muscle tissue on tissue oxygenation measured by near-infrared spectroscopy--a pilot study. BMC Anesthesiol. 2014 Jul 15;14:54. doi: 10.1186/1471-2253-14-54. eCollection 2014.

    PMID: 25132803DERIVED

Study Officials

  • Axel Fudickar, Dr.

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 16, 2014

Study Start

May 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

DE(1)