Trial document




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  DRKS00016645

Trial Description

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Title

Bile Acids in Serum and broncho-alveolar lavage fluid

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Trial Acronym

BASeBAL

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The current scientific literature suggests a possible, previously unmentioned factor in the development of lung failure, which could contribute to the triggering or worsening of a lung failure. The present study aims to investigate this factor. This factor is bile acids, as they are necessary for the digestion of dietary fats. In recent years, there is increasing evidence that bile acids not only have a function in the intestine, but also perform functions as a messenger in the blood. However, if the concentration of bile acids in the blood exceeds the normal level, the bile acids may enter the lungs via the bloodstream in too high a concentration, triggering or intensifying lung damage by digesting fats according to their function the lung function is absolutely necessary. With this study we want to prove this connection. For this we need a small amount of blood at several times during the stay in the intensive care unit. In addition, we need lung fluid, which is obtained at the same time as the blood sampling in the context of routine lung fiberoptic examinations. The additional burden of the study is limited to the withdrawal of blood from already inserted vascular access and the removal of a small amount of lung fluid, which are not harmful. In addition, certain parameters are taken from the patient record in order to accurately assess the severity of the disease, which is important for the evaluation of the results. Hopefully, for future patients with the same disease, a mechanism can be discovered by preventing it, e.g. by administering certain medications, the course of the disease can be positively influenced.

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Brief Summary in Scientific Language

Bile acids are amphiphilic molecules whose primary function is to emulsify dietary fats; under physiological conditions only small amounts are found in the serum. Due to their properties, bile acids in the alveolar fluid can cause lung damage by emulsifying surfactant. This mechanism has been demonstrated for gastrointestinal reflux, in animal experiments as well as in neonatal respiratory distress syndrome. In critically ill patients there is often an endothelial disorder with loss of barrier function ("capillary leak"). The barrier disorder leads to the transfer of water and some proteins in the alveoli. It is conceivable that the disturbed endothelial barrier in the lungs also causes bile acids to pass into the alveoli, which then render surfactant inoperable and on this basis trigger an ARDS or aggravate an existing ARDS.

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Organizational Data

  •   DRKS00016645
  •   2019/01/30
  •   [---]*
  •   yes
  •   Approved
  •   19/7/18, 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

  •   J80.09 -  [generalization J80: Adult respiratory distress syndrome]
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Interventions/Observational Groups

  •   Patients with ARDS
    At four time points (day of diagnosis and three other clinically indicated times), bronchoalveolar lavage is performed and material is collected. At the same time a serum sample is obtained. The concentrations of bile acids in the bronchoalveolar lavage fluid and the serum are examined and correlated with laboratory chemistry.
  •   lunghealthy control
    This group is recruited from healthy patients who receive tracheotomy for non-pulmonary reasons (e.g., persistent dysphagia after neurological disorders). The standard bronchoscopy-assisted percutaneous dilatation tracheotomy also routinely performs bronchoscopy, which involves obtaining a sample for examination. At the same time a serum sample is obtained. The concentrations of bile acids in the bronchoalveolar lavage fluid and the serum are examined and correlated with laboratory chemistry.
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Characteristics

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

Demonstration of a barrier disorder of the lung for bile acids
Detection of a linear relationship bile acids serum - bronchalveolar lavagefluid (BAL fluid)

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Secondary Outcome

Evidence of a correlation bile acids BAL fluid - ARDS severity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/02/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• Women and men
• Age> 18 years <90 years
• Patients in the operative intensive care unit of the Department of Anaesthesiology (0119)
• Diagnosis of ARDS (control group without impaired lung function)
• There is an oral and / or written explanation
Presence of written consent (patient / legal representative)

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Exclusion Criteria

• No consent
Rejection study participation

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Addresses

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    • Universitätsmedizin Göttingen Klinik für Anästhesiologie
    • Mr.  Dr.  Lars-Olav  Harnisch 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen Klinik für Anästhesiologie
    • Mr.  Dr.  Lars-Olav  Harnisch 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • Germany
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    • Universitätsmedizin Göttingen
    • Mr.  Dr.  Lars-Olav  Harnisch 
    • Robert-Koch-Straße 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen Klinik für Anästhesiologie
    • Mr.  Dr.  Lars-Olav  Harnisch 
    • Robert-Koch Str. 40
    • 37075  Göttingen
    • 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.