Trial document




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  DRKS00013583

Trial Description

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Title

CERebral Blood flow Evaluation and Regulation by UltraSound to improve neurocognitive outcome after cardiopulmonary bypass

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Trial Acronym

CERBERUS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Cardiopulmonary bypass (CPB) is one of the Standard procedures in cardiac surgery.
Besides cardiopulmonary complications the method carries also a significant risk of cognitive alterations and postoperative delirium (POD). POD still represents a considerable Problem and is associated with worse postoperative outcome. The mechanisms of POD are still poorly understood and may be multifactorial, making prevention difficult.

In a previous observational study we found a relationship between relative cerebral hyperperfusion during cardiopulmonary bypass and postoperative delirium. We also found a decrease in baseline middle cerebral artery (MCA) flow velocity with age. It is currently unclear if a reduced baseline cerebral blood flow or intraoperative hyperperfusion or both contribute to POD.
We will test in a randomized controlled trial if a CPB management individually adapted to cerebral hemodynamics as continuously assessed by ultrasound of the MCA improves neurocognitive outcome.

Primary goal of this study is the reduction of POD by avoidance of intraoperative hyperperfusion as measured by transcranial ultrasound by means of individualized cardiopulmonary bypass flow.

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Organizational Data

  •   DRKS00013583
  •   2018/03/19
  •   [---]*
  •   yes
  •   Approved
  •   375/17, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

  •   F05.8 -  Other delirium
  •   U51 -  [---]*
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Interventions/Observational Groups

  •   Hemodynamic Management according to standard procedure
  •   Individualized hemodynamic Management: In case MCA (middle cerebral artery) velocity is higher than baseline reduction of CPB (cardiopulmonary bypass) flow in 10% steps until baseline is reached
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

POD on first 3 postoperative days as assessed by the confusion assessment method (CAM) or CAM-ICU test (confusion assessment method for the intensive care unit) on the first 3 postoperative days

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Secondary Outcome

postoperative cognitive deficit on 6. postoperative day as assessed by the 6-item screening test

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/05/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

cardiac surgery with CPB, valve surgery, coronary artery bypass

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Exclusion Criteria

emergency procedures, aortic arch surgery, hypothermic perfusion <32°C

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Addresses

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    • Universitätsklinikum Bonn
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn
    • Mr.  Dr. med.  Marcus  Thudium 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn
    • Mr.  Dr. med.  Marcus  Thudium 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum BonnKlinik für Anästhesiologie
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.