Trial document




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  DRKS00007805

Trial Description

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Title

Optimizing cardiac out-Put To Increase cerebral penumbral perfusion in large Middle cerebral Artery ischemic Lesion

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Trial Acronym

OPTIMAL-Study

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URL of the Trial

http://www.dgni.de/forschung/ignite-initiative-klinischer-multizenter-studien/aktuelle-forschungsprojekte/vaskulaere-erkrankungen-ischaemie/474-optimal.html

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Early optimization of the penumbral perfusion in ischemic stroke is essential to minimize the final infarction volume and to improve the clinical outcome. So far, mean arterial blood pressure (MAP) is used as a standard target parameter for improving cerebral perfusion being a readily accessible monitoring parameter on one side and expected to be related to cerebral perfusion due to vascular autoregulation of the brain and perfusion pressure on the other. MAP depends on cardiac output and systemic vascular resistance. Therefore, MAP-values and cardiac output are assumed to correlate.
Oxygen supply is crucial for organ function, especially for cerebral structures. Organ perfusion and oxygen supply are dependent on cardiac output. It has been shown that early optimization of cardiac output and secondary oxygen supply leads to an improvement of the functional outcome of critical ill.
However, studies of patients demonstrated that MAP and cardiac output and secondary organ perfusion correlate poorly as they are dependent on volume state and other parameters (such as peripheral vascular resistance). Cardiac output might therefore be an additional target parameter in order to optimize cerebral perfusion.
Data on patients with subarachnoidal hemorrhage suggest that cardiac output is an essential parameter for cerebral perfusion: incresase of cardiac output during constant MAP-levels improved cerebral perfusion and, more importantly, the functional outcome of patients.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00007805
  •   2015/02/16
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  •   yes
  •   Approved
  •   438/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I63.4 -  Cerebral infarction due to embolism of cerebral arteries
  •   I63.0 -  Cerebral infarction due to thrombosis of precerebral arteries
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Interventions/Observational Groups

  •   stroke patients with ischemic infarction (>30% of the territory of the middle cerebral artery); standard monitoring; optimization of MAP>80mmHg; volume substitution or, if necessary, catecholamine (noradrenaline) administration in order to increase MAP >80mmHg
  •   stroke patients with ischemic infarction (>30% of the territory of the middle cerebral artery); standard monitoring plus monitoring of cardiac output; optimization of MAP and cardiac output (MAP>80mmHg, cardiac output >3.0 and <4.5); volume substitution or, if necessary, catecholamine (noradrenaline, dobutamine) administration in order to optimize hemodynamic parameters
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Characteristics

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

Clinical outcome after 3 months (modified Rankin Scale)

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Secondary Outcome

Clinical outcome after 6 months (modified Rankin Scale); in-hospital mortality; length of in-hospital stay; symptomatic cerebral hemorrhage; final infarction volume

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/02/16
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

age >18 or <85years; ischemic infarction via computer tomography or magnetic resonance tomography; ≥30% of the territory of middle cerebral artery; begin of symptoms <12hours

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Exclusion Criteria

i.v.-thrombolysis with rtPA; intracerebral hemorrhage; pre-existing disablement according to a modified Rankin score >2; malignant disease

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Addresses

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    • Klinik für Neurologie, Universitätsklinikum Freiburg
    • Mr.  Dr.  Wolf-Dirk  Niesen 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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    • Klinik für Neurologie, Universitätsklinikum Freiburg
    • Ms.  Dr.  Hannah  Fuhrer 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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    • Klinik für Neurologie, Universitätsklinikum Freiburg
    • Ms.  Dr.  Hannah  Fuhrer 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neurologie, Universitätsklinikum Freiburg
    • 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.