Abstract
BACKGROUND: To characterize current clinical practices and outcomes associated with the use of the extracorporeal blood purification (EBP) device Oxiris® in critically ill patients. METHODS: This was a prospective clinical registry database that analyzed patients treated with Oxiris®. Three different clusters of critically ill patients were identified: Group A-patients with chronic kidney disease and systemic inflammation who required postoperative support of renal function; Group B-patients requiring immunomodulation without definitive indications for renal support; Group C-patients with abdominal septic shock necessitating both postoperative renal support and immunomodulation. The primary endpoint was the comparison between mortality rates predicted by the Simplified Acute Physiology Score II (SAPS II) and observed mortality rates 4 days after EBP initiation. RESULTS: Observed 4-day mortality rates were markedly lower than SAPS II-predicted rates: 16.7% vs. 41% in Group A, 30.8% vs. 77% in Group B, and 21.3% vs. 83% [66;89] in Group C. Early mortality was significantly associated with baseline hemodynamic instability (vasopressor requirement, OR = 3.62 [1.59-9.80], p = 0.005) and a lower PaO₂/FiO₂ ratio (OR = 0.99 [0.98-0.99], p = 0.001). CONCLUSIONS: The removal of inflammatory mediators and microbial components is an emerging therapeutic target for Oxiris® use. Oxiris® may offer therapeutic benefit through the removal of inflammatory mediators in critically ill patients with severe systemic inflammation and renal failure. Although observed mortality was lower than historical estimates, these findings must be interpreted cautiously given the lack of a control group and the limitations of SAPS II. Controlled trials are needed to confirm its clinical impact. TRIAL REGISTRATION: The study was registered on ClinicalTrials.gov (Identifier: NCT03807414; Registration Date: June 28, 2019).