ARTISTRY - ARTICE4 Therapy Registry Study

What this Trial Is About

This research focuses on adults with sepsis, septic shock, or immunoparalysis in septic shock who are planned to receive ARTICE4 therapy during their ICU stay. The study aims to collect real-world data on the use of ARTICE4 therapy, further evaluate its treatment effects, identify potential patient subgroups, and assess safety and risk-benefit profiles. A key measure is the change in SOFA score from day 0 to day 7 or after the last ARTICE4 treatment. Participants will receive ARTICE4 therapy as part of their standard ICU care. The study observes changes over a period up to 7 days after the last ARTICE4 treatment, monitoring various clinical and laboratory parameters. These include physiological signs such as heart rate, blood pressure, body temperature, mean arterial pressure, and markers of inflammation. The study also tracks hospital survival rates, length of ICU stay, days requiring mechanical ventilation, renal replacement therapy, vasopressor therapy, and incidence and types of secondary infections. During the study, researchers will collect data from enrollment through 7 days after the last ARTICE4 treatment. They will monitor clinical scores like SOFA and Apache II, laboratory biomarkers, and any complications related to ARTICE4 therapy. This observational study does not involve experimental treatment assignments but gathers detailed real-life information to better understand ARTICE4 therapy outcomes in critically ill patients with sepsis and related conditions.

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