Trial document





This trial has been registered retrospectively.
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  DRKS00009632

Trial Description

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Title

Aortic blood flow velocity variation as a predictor of fluid responsiveness in patients during coronary artery bypass surgery

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Trial Acronym

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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

The purpose of this study is to compare between well established parameters to describe patients' fluid responsiveness (SVV, PPV) and the values aquired by doppler-imaging via trans-esophageal echocardiography in the LVOT and the aorta desendens at the same time within the same patient.
As a secondary goal. we evaluate if the cardiac output of the patient measured via echocardiography is comparable to the cardiac output measured by pulse-contour-analysis.
To achieve this, we observe Patients scheduled for elective coronar arterial bypass grafting. The Patients arterial line, which is placed in the patients radial artery following our department standards is therefore connected to a device that performs pulse-contour-analysis (Pulsioflex). The transesophagel echocardiography is performed also following our department standards. On 3 defined points during the operation, the PPV, SVV and CO are measured by pulse contur analysis and the blood flow velocity and cardiac stroke volume is measured by TOE in the LVOT and the aorta descendens.

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Organizational Data

  •   DRKS00009632
  •   2016/01/05
  •   [---]*
  •   yes
  •   Approved
  •   S-583/2014, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1179-7486 
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Health Condition or Problem studied

  •   Fluid Responsiveness
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Interventions/Observational Groups

  •   Comparison of the stroke volume variation (SVV) and the pulse pressure variation (PPV) derived by pulse contour analysis with the variations of the blood flow velocity in the LVOT and the aorta descendens measured with doppler-imaging by echocardiography. Both measurements are done at the same time in the same patient simultaneously.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary goal of this study is to proof that the parameters measured by echocardiography to describe the fluid responsiveness are comparable to the paramters derived by pulse contour analysis.

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Secondary Outcome

The secondary goal of this study is to show that the cardiac output measured by echocardiography is comparable to the cardiac output measured by pulse contour analysis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/05/01
  •   30
  •   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

Adult patients who were scheduled for coronary artery bypass grafting

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Exclusion Criteria

Permanent absence of cardiac sinus rhythm (i.e. atrial fibrillation), highly impaired left and/or right ventricular function (ejection fraction <30%). mid- or high grade valve stenosis and/or insufficieny. Contraindications to transesophageal echocardiography.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.   Markus  Weigand 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Mr.  Dr. med  Adrian  Stephan 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Dr. med  Adrian  Stephan 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Ärztlicher DirektorKlinik für AnästhesiologieUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr.   Markus  Weigand 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/04/11
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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.