Observational Trial on Cytokine Adsorption in Sepsis
NCT04306419 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2022-11-04
Summary
To determine the specific population of critically ill septic patients who benefit most from cytokine adsorption therapy with the HA-380 cartridge. Benefit of the treatment will be assessed on the basis of:
* The scope of the effect of cytokine adsorption therapy in this specific population of critically ill patients expressed by cytokine variability within the patients
* The scope of cytokine changes in passing the adsorption cartridge my measuring cytokine levels in the patient's blood directly before passing through the cartridge and directly after having passed through the cartridge.
* The scope of changes in organ dysfunction expressed by SOFA scores that are repeatedly calculated during the treatment with cytokine adsorption and then daily until day 7 of the ICU treatment.
* The scope of changes on cellular function on immune cells in serum samples taken before and after cytokine adsorption therapy.
* The scope of removal of anti-infective drugs from the blood in passing through the cytokine adsorption cartridge by measuring antibiotic drug levels in the patients blood during the cytokine adsorption therapy
* 30 day and 90 day mortality and location status in survivors
Conditions
- Sepsis
- Septic Shock
- Multiple Organ Failure
Sponsors & Collaborators
-
RWTH Aachen University
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-15
- Primary Completion
- 2023-06-28
- Completion
- 2024-05-31
Countries
- Germany
Study Locations
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