Trial document
DRKS00017211
Trial Description
Title
Change of microcirculation with haemoadsorption in patients with sepsis and septic shock
Trial Acronym
MiHaS
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.
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.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00017211
- 2019/07/30
- [---]*
- yes
- Approved
- 2019-440, Ethikkommission der Medizinischen Fakultät der Ruhr-Universität Bochum, Sitz Bad Oeynhausen
Secondary IDs
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Health Condition or Problem studied
- A41.9 - Sepsis, unspecified
- R57.2 - Septic shock
Interventions/Observational Groups
- Patients with sepsis and haemoadsorption
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
Primary Outcome
Change of mucosal microcirculation during haemoadsorption.
Secondary Outcome
Change of liver function during haemoadsorption.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2020/03/20
- 30
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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
Exclusion Criteria
1) pregnancy
2) breastfeeding women
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinik für Anästhesiologie, operative Intensivmedizin, Rettungsmedizin, SchmerztherapieKlinikum Herford AöR
- Schwarzenmoorstraße 70
- 32049 Herford
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
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- https://www.klinikum-herford.de/
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start of 1:1-Block address scientific-contact
- Universitätsklinik für Anästhesiologie, operative Intensivmedizin, Rettungsmedizin, SchmerztherapieKlinikum Herford AöR
- Mr. Prof. Dr. med. Dietrich Henzler
- Schwarzenmoorstraße 70
- 32049 Herford
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 (0)5221 94 2481
- +49 (0)5221 94 2801
- dietrich.henzler at klinikum-herford.de
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinik für Anästhesiologie, operative Intensivmedizin, Rettungsmedizin, SchmerztherapieKlinikum Herford AöR
- Mr. Prof. Dr. med. Dietrich Henzler
- Schwarzenmoorstraße 70
- 32049 Herford
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 (0)5221 94 2481
- +49 (0)5221 94 2801
- dietrich.henzler at klinikum-herford.de
- [---]*
end of 1:1-Block address contact public-contact
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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- [---]*
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start of 1:1-Block address otherSupport
- CytoSorbents Europe GmbH
- Müggelseedamm 131
- 12587 Berlin
- Germany
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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