Trial document





This trial has been registered retrospectively.
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  DRKS00003107

Trial Description

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Title

prospective comparison of microcirculation during surface- vs: endovascular cooling after successful treatment reanimation

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Trial Acronym

OEKER-Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Comparison of the microcirculation in treatment with one of two different cooling methods (through the skin / inside the blood vessels) after successful resuscitation by non-invasive measurements of peripheral blood flow.

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Brief Summary in Scientific Language

Comparison of microcirculation during surface- versus endovascular cooling method by measuring with non-invasive near infrared spectroscopy.

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Organizational Data

  •   DRKS00003107
  •   2011/05/30
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  •   yes
  •   Approved
  •   183/10, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I46.0 -  Cardiac arrest with successful resuscitation
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Interventions/Observational Groups

  •   Surface cooling method with Thermowrap system (airflow system via blankets)
    Microcirculation measurement: 1. at admission, 2. After receiving target bodytemperature of 33C (24 h), 3. after rewarming (48 h).
    The 7-day Follow up and 30-day FU with performing Glasgow Coma Scale and Glasgow Outcome Scale
  •   endovascular cooling method with Coolgard system (catheter based system to decrease the central bodytemperature)
    Microcirculation measurement: 1. at admission, 2. After receiving target bodytemperature of 33C (24 h), 3. after rewarming (48 h).
    The 7-day Follow up and 30-day FU with performing Glasgow Coma Scale and Glasgow Outcome Scale
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Diagnostic
  •   Parallel
  •   N/A
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Primary Outcome

Analysis of the microcirculation by means of NIRS (near infrared spectroscopy) in combination with occlusion of an upper arm (VOT, vascular occlusion test), analysis of capillary refill time in extremities

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Secondary Outcome

30 days mortality, cooling times, Neurological Outcome, complications, collection of clinical outcome parameters such as SOFA score, APACHE II, Glasgow Coma Scale (GCS) and Glasgow Outcome Score (GOS) and as part of standard bloodsamples biochemical studies to evaluate the consecutive end-organ damage and the activation of plasma coagulation system

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/10/22
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients after successful resuscitation

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Exclusion Criteria

Pregnancy, contraindication to cool, living will, morbid obesity (BMI> 40)

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Addresses

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    • Uniklinik Freiburg, Medizinische Klinik, ,
    • Mr.  Dr.  Hans-Jörg  Busch 
    • Hugstetterstr. 55
    • 79106   Freiburg
    • Germany
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    • Uniklinik Freiburg, Medizinische Klinik, ,
    • Mr.  Dr.  Hans-Jörg  Busch 
    • Hugstetterstr. 55
    • 79106   Freiburg
    • Germany
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    • Uniklinik Freiburg, Medizinische Klinik, ,
    • Mr.  Dr.  Hans-Jörg  Busch 
    • Hugstetterstr. 55
    • 79106   Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg
    • Mr.  Dr.  Hans-Jörg  Busch 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.