Trial document





This trial has been registered retrospectively.
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  DRKS00009746

Trial Description

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Title

Critical care echocardiography as a routine versus an acute procedure for the detection and early treatment of cardiac pathologies

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

This current study evaluates the range and prevalence of echocardiographically detectable cardiac pathologies in intensive care patients.

ICU-patients above 18 years of age are included in the study on their third day in the intensive care unit.

Patients treated in a palliative concept and patients with a cardiac admission diagnosis are excluded from the study.

Included patients are subjected to a thransthoracic expert echocardiographic evaluation on their third day of the ICU stay.

Echocardiographic results will be scientifically analysed and correlated with further apparative, clinical und laboratory tests.

The following target parameters will be evaluated:

- Range and prevalence of cardiac diseases in intensive care patients detected by cardiac ultrasonography
- Survial of intensive care patients with cardiac diseases
- Statistical analysis for the presence of cardiac diseases by ECGs and lung x-ray interpretation
- Quality of cardiac ultrasonography images acquired in the ICU
- Prediction of cardiac diseases by special scoring systems in the intensive care unit

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Brief Summary in Scientific Language

In addition to the brief summary in lay language the following parameters will be scientifically evaluated:

- Range and prevalence of cardiac pathologies in ICU patients by transthoracic echocardiography
- Survival of ICU patients with echocardiographically detectable cardiac pathologies
- Sensitivity, specificity, positive predictive value, negative predictive value for the presence of cardiac pathologies detected by ECG and chest x-ray interpretation
- Transthoracic image quality in ICU patients
- Prediction of cardiac pathologies by established ICU parameters (SAPS II; days in intensive care, etc.)

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Organizational Data

  •   DRKS00009746
  •   2016/02/10
  •   [---]*
  •   yes
  •   Approved
  •   11/12/13, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   I00-I99 -  Diseases of the circulatory system
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Interventions/Observational Groups

  •   Patients that met the inclusion criteria will be subjected to an extensive expert echocardiographic evaluation of cardic pathologies on the third day of their ICU stay. The following tests will be conducted:

    - extensive expert echocardiographic evaluation by thransthoracic echocardiography on the third day of the ICU stay

    - ECG and chest x-ray analysis by the attending consultant and resident (for later correlation with echocardiographic pathologies)

    - questionnaire answered by the attending consultant and resident regarding relevance and usefulness of the echocardiographic evaluation.

    No invasive tests tests will be conducted.
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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
  •   No
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Primary Outcome

Evaluation of the range and prevalence of cardiac pathologies in ICU patients as following:

- Range and prevalence of cardiac pathologies in ICU patients by transthoracic echocardiography (extensive expert echocardiographic evaluation on the third day in the intensive care unit)

- Survival of ICU patients with echocardiographically detectable cardiac pathologies (clinical parameters investigated during the stay in intensive care, Kaplan-Meier survical analysis)

- Sensitivites, specificities, positive predictive values, negative predictive values for the presence of cardiac pathologies detected by ECG and chest x-ray interpretation (correlation of ECG and chest x-ray interpretation conducted during day 1-3 in the intensive care unit with echocardiographic detectable cardiac pathologies conducted on the third day of the intensive care stay)

- Transthoracic image quality in ICU patients (evaluation on the third day in intensive care by thransthoracic echocardiography)

- Prediction of cardiac pathologies by established ICU parameters (SAPS II; days in intensive care, etc.) [echocardiographic evaluation from the third day in intensive care and clinical parameters from the entire stay in the intensive care unit]

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Secondary Outcome

In addition the the primary endpoints the following secondary endpoint will be evaluated:

- relevance and usefulness of the echocardiographic evaluation on the third day of the ICU stay determined by a questionaire answered by the attending resident and consultant

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/03/24
  •   111
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Consecutive intensive care patients on their third day in the ICU

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Exclusion Criteria

Cardiac admission diagnosis,
palliative treatment

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Addresses

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Universitätsklinikum GöttingenKlinik für Anästhesiologie
    • Mr.  Dr. med.  Stefan  Schmidt 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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    • Universitätsklinikum GöttingenKlinik für Anästhesiologie
    • Mr.  Dr. med.  Stefan  Schmidt 
    • Robert-Koch-Str. 40
    • 37099  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/07/31
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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.