Treatment Study for Adults with Severe Septic Shock Using Immune Cell Extracorporeal Therapy Plus Standard Care

What this Trial Is About

This trial investigates a new therapy approach for adults with severe sepsis and septic shock. Researchers are studying whether adding an immune cell perfusion system, called ARTICE, to the standard treatment helps improve organ function by supporting the weakened immune system in these critically ill patients. Participants are randomly assigned to one of two groups one receiving the ARTICE immune cell extracorporeal therapy alongside standard care, and the other receiving standard care alone. ARTICE uses purified granulocyte concentrate in an extracorporeal treatment system. The therapy is given shortly after diagnosis of septic shock, which must be recent, within 48 hours before starting the study. During the study, participants will be closely monitored with various assessments including safety checks for serious side effects from day 2 to day 28. Researchers will also track survival rates, organ function scores, inflammatory markers, time to organ recovery, length of ICU and hospital stays, days free from mechanical ventilation and antibiotics, and quality of life up to 90 days. The total observation includes early safety and longer-term outcomes to evaluate the therapys impact.

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