Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation – randomized, controlled, open-label intervention, multi-center trial
Not Applicable
- Conditions
- U07.1COVID-19, virus identified
- Registration Number
- DRKS00021248
- Lead Sponsor
- niversitätsklinikum Freiburg, Klinik für Innere Medizin III
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Adult patient (= 18 years), initiation of vv-ECMO, SARS-CoV-2-infection
Exclusion Criteria
Known or presumed patient will against participation in the study or against the measures applied in the study, a decision (made prior to inclusion of the patient into this trial) to terminate the treatment within the next 24 hours
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) IL-6 reduction by 75 % or more after 72 hours as compared to the baseline measurement, (2) time to successful ECMO-explantation within 30 days after randomization.
- Secondary Outcome Measures
Name Time Method • Ventilator free days (VFD) in the first 30 days after randomization, where invasive mechanical ventilation (IMV), non-invasive ventilation (NIV) and ECMO are defined as ventilator days. VFD=0, if the patient dies in the first 30 days after randomization<br>• Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. <br>• Overall survival time, defined as time from randomization to death.<br>• Days on intensive care unit (ICU)<br>• Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48, 72 h<br>• Fluid substitution and fluid balance at 24, 48, 72 h <br>• Serum lactate at 24, 48, 72 h <br>• Urine output at 24, 48, 72 h <br>• Willebrand factor at 24, 48, 72 h <br>• d-dimers at 24, 48, 72 h<br>• interleukin-6 levels at 24, 48, 72 h<br>• SOFA-score at 24, 48, 72 h<br>• Adverse events of special interest (AESI) as defined in the clinical trial protocol<br>