Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy

Exclusion Criteria

• •1. Acute or chronic leukemia,
• •2. Bilirubin ≥ 2 mg/dL (≥33 µmol/L),
• •3. Ongoing (concomitant) or prior within the last 6 month any chemotherapy or radiotherapy for malignancy,
• •4. Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent,
• •5. Previous transplantation,
• •6. Subjects receiving interferon therapy (14 days prior randomisation),
• •7. Acute pulmonary embolism within the last 72 hours,
• •8. Ischemic stroke or intracranial bleeding within the last 3 months
• •9. Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG within the last 72 hours,
• •10. Cardiopulmonary resuscitation within last 7 days,
• •11. Moribund subject (life expectancy \<72 hours), in the judgement of the investigator
• •12. Presence of a do-not-resuscitate or do-not-intubate order,
• •13. Known HIV infection or chronic viral hepatitis,
• •14. Isolated Urosepsis,
• •15. Pregnancy/nursing period,
• •16. Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure/cardiogenic shock),
• •17. Previous sepsis with ICU admission within this hospital stay,
• •18. Known/suspected acute mesenteric ischaemia,
• •19. Chronic mechanical ventilation for any reason OR severe COPD requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days,
• •20. Decision to limit full care taken before obtaining informed consent,
• •21. Prior enrolment in the trial,
• •22. Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or device,
• •23. multiple injuries including polytrauma and burn \>20% TBSA (2° or 3°),
• •24. Diagnosed and documented pre-existing dementia,
• •25. Severe Covid-Pneumonia