Status:
UNKNOWN
Observational Trial on Cytokine Adsorption in Sepsis
Lead Sponsor:
RWTH Aachen University
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Brief 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 bas...
Detailed Description
1. Medical Problem Sepsis, a syndrome of physiologic, pathologic, and biochemical abnormalities induced by infection. It is a major public health concern, accounting for more than $20 billion (5.2%) o...
Eligibility Criteria
Inclusion
- \>18 years of age
- diagnosis of sepsis or septic shock with at least 2 organ-dysfunctions defined by SOFA score
- baseline serum IL-6 \> 1000 pg/ml, IL-10 levels \>250 pg/ml or TNF-alpha levels \> 100 ng/l. The baseline IL-6 measurement must be on the same calendar day that the cytokine adsorption is started, the baseline IL-10 or TNF-alpha can be taken up to 36h before because of higher turn-around times for these tests.
- need for CRRT or ECMO therapy
Exclusion
- Solid organ malignancies with or without treatment
- Participation or enrollment in another clinical study within 30 day
- Pregnant and lactating females If women of childbearing potential will be enrolled, a pregnancy test will be performed by assessing the value of ß-HCG in the routinely drawn blood and or urine.
- Patient has been committed to an institution by legal or regulatory order
- Participation in a parallel interventional clinical trial
- The subject received an investigational drug within 30 days prior to inclusion into this project
Key Trial Info
Start Date :
November 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04306419
Start Date
November 15 2020
End Date
May 31 2024
Last Update
November 4 2022
Active Locations (1)
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1
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074