Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005851

Trial Description

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Title

Influence of Sevoflurane Preconditioning on Tissue Oxygenation of the Tibial Anterior Muscle Measured by Near-infrared Spectroscopy After Clamping of the Femoral Artery for Vascular Surgery

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Trial Acronym

NIRSFEM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

Ischemic preconditioning is performed by clamping of the femoral artery for five minutes in
40 patients. In 20 patients sevoflurane preconditioning is performed five minutes before
ischemic preconditioning by inducing sevoflurane anesthesia for five minutes. Muscle tissue
oxygenation is measured bilaterally in the anterior tibial muscle by near-infrared
spectroscopy (INVOS, SOMANETICS, Troy, Michigan/ USA) during preconditioning and following
ischemia.Clinically relevant ischemia was defined as a decrease of tissue oxygen saturation
to 95 % of baseline.

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Organizational Data

  •   DRKS00005851
  •   2015/02/18
  •   2014/01/14
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT02038062  (ClinicalTrials.gov)
  •   Fudickar7  (University of Schleswig-Holstein)
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Health Condition or Problem studied

  •   Tissue Oxygen Saturation.
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Interventions/Observational Groups

  •   Procedure: Sevoflurane preconditioning
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
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Primary Outcome

- Decrease of tissue oxygen saturation below 95 % of baseline; time frame: 4 hours; Decrease of tissue oxygen saturation below 95 % of baseline

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2010/05/31
  •   40
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

vascular surgery with clamping of a femoral artery. -

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Exclusion Criteria

-

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Addresses

  • start of 1:1-Block address primary-sponsor
    • University of Schleswig-Holstein
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    • University Hospital Schleswig-Holstein, Campus Kiel
    • Axel Fudickar, Dr. 
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    •   [---]*
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    • University Hospital Schleswig-Holstein, Campus Kiel
    • Axel Fudickar, Dr. 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2012/01/01
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.