Trial document




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  DRKS00017211

Trial Description

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Title

Change of microcirculation with haemoadsorption in patients with sepsis and septic shock

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Trial Acronym

MiHaS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Sepsis is a life-threatening disease caused by an exaggerated and misdirected immune reaction of the body to an infection. In the course the blood circulation decreases which has also an impact on the mucous membranes.
The aim of this study ist to investigate, whether the use of a Cytokine-Adsorber that shall reduce the exaggerated immune reaction improves the blood circulation in mucous membranes as well as the liver function.

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Brief Summary in Scientific Language

Sepsis is a life-threatening organ disfunction caused by an inadequate, misdirected host response to an infection. In the course of the sepsis the microcirculation in the mucosa is reduced.
The aim of this study is to investigate, whether the use of a Cytokine-Adsorber and the connected reduction of all pro- and anti inflammatory active cytokines improves the mucosal microcirculation as well as liver function.

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Organizational Data

  •   DRKS00017211
  •   2019/07/30
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  •   yes
  •   Approved
  •   2019-440, Ethikkommission der Medizinischen Fakultät der Ruhr-Universität Bochum, Sitz Bad Oeynhausen
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Secondary IDs

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Health Condition or Problem studied

  •   A41.9 -  Sepsis, unspecified
  •   R57.2 -  Septic shock
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Interventions/Observational Groups

  •   Patients with sepsis and haemoadsorption
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Change of mucosal microcirculation during haemoadsorption.

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Secondary Outcome

Change of liver function during haemoadsorption.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/08/01
  •   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

1) presence of sepsis according to the current sepsis 3-definition or presence of septic shock according to the current sepsis 3-definition
2) presence of an anus praeter

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Exclusion Criteria

1) pregnancy
2) breastfeeding women

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Addresses

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    • Universitätsklinik für Anästhesiologie, operative Intensivmedizin, Rettungsmedizin, SchmerztherapieKlinikum Herford AöR
    • Schwarzenmoorstraße 70
    • 32049  Herford
    • Germany
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    • Universitätsklinik für Anästhesiologie, operative Intensivmedizin, Rettungsmedizin, SchmerztherapieKlinikum Herford AöR
    • Mr.  Prof. Dr. med.  Dietrich  Henzler 
    • Schwarzenmoorstraße 70
    • 32049  Herford
    • Germany
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    • Universitätsklinik für Anästhesiologie, operative Intensivmedizin, Rettungsmedizin, SchmerztherapieKlinikum Herford AöR
    • Mr.  Prof. Dr. med.  Dietrich  Henzler 
    • Schwarzenmoorstraße 70
    • 32049  Herford
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Anästhesiologie, operative Intensivmedizin, Rettungsmedizin, Schmerztherapie der Ruhr-Universität Bochum am Klinikum Herford
    • 32049  Herford
    • Germany
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    • CytoSorbents Europe GmbH
    • Müggelseedamm 131
    • 12587  Berlin
    • 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.