ARTISTRY Registry Study for ARTICE4 Therapy Use in Adults with Sepsis and Septic Shock

What this Trial Is About

Researchers are collecting real-life data on the use of ARTICE4 therapy in people with sepsis, septic shock, and immunoparalysis in septic shock. This observational phase 4 study aims to further evaluate how ARTICE4 treatment works, identify specific patient sub-groups, and assess the risks and safety of the therapy. A key focus is tracking changes in the Sequential Organ Failure Assessment SOFA score from the start of treatment to seven days after. Participants planned to receive ARTICE4 therapy during their intensive care unit ICU stay will be observed. The study does not involve assigning new treatments but records data related to ARTICE4 as given in routine care. Data collection covers the period from enrollment up to seven days after the last ARTICE4 treatment. During the study, various health measures will be monitored, including changes in SOFA scores and its sub-scores, standard laboratory and inflammatory biomarkers, hospital survival rates, length of ICU stay, days on mechanical ventilation, renal replacement therapy, and vasopressor use. The study also tracks the frequency and types of secondary infections, physiological parameters like heart rate and blood pressure, and any complications related to ARTICE4 therapy. The overall participation duration depends on the timing of ARTICE4 treatment and follow-up up to seven days after.

ARTICE® Real Data Collection & Observational Trial, Phase 4 Study