Trial document

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DRKS-ID: 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

DRKS-ID: DRKS00017211
Date of Registration in DRKS: 2019/07/30
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 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

ICD10: A41.9 - Sepsis, unspecified
ICD10: R57.2 - Septic shock

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Interventions/Observational Groups

Arm 1: Patients with sepsis and haemoadsorption

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Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Basic research/physiological study
Assignment: Single (group)
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

University Medical Center Universitätsklinik für Anästhesiologie, op. Intensivmedizin, Rettungsmedizin, Schmerztherapie der Ruhr-Universität Bochum, Campus OWL, Klinikum Herford, Herford

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Recruitment

Planned/Actual: Planned
(Anticipated or Actual) Date of First Enrollment: 2019/08/01
Target Sample Size: 30
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Universitätsklinik für Anästhesiologie, operative Intensivmedizin, Rettungsmedizin, SchmerztherapieKlinikum Herford AöR
- Schwarzenmoorstraße 70
- 32049 Herford
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: https://www.klinikum-herford.de/
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Contact for Scientific Queries
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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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- Telephone: +49 (0)5221 94 2481
- Fax: +49 (0)5221 94 2801
- E-mail: dietrich.henzler at klinikum-herford.de
- URL: [---]*
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Contact for Public Queries
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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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- Telephone: +49 (0)5221 94 2481
- Fax: +49 (0)5221 94 2801
- E-mail: dietrich.henzler at klinikum-herford.de
- URL: [---]*
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Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
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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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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- CytoSorbents Europe GmbH
- Müggelseedamm 131
- 12587 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting planned
Study Closing (LPLV): [---]*

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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.