Endotoxin removal by the OXIRIS filter for cardiogenic shock requiring veno-arterial extra-corporeal life support: the ECMORIX randomized controlled trial

Abstract

Background: Most severe cardiogenic shock requires veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The OXIRIS filter, has shown potential in reducing lipopolysaccharide (LPS) levels. Our objective was to compare the efficacy of the OXIRIS filter versus the ST-150 filter in reducing LPS plasma concentration. We hypothesized that the OXIRIS filter would reduce the endotoxin burden. Methods: We conducted an open-label randomized prospective study in the cardiac intensive care unit of Dijon University Hospital. Forty patients with refractory cardiogenic shock requiring VA-ECMO and renal replacement therapy (RRT) were randomized to receive either OXIRIS filter or ST-150 filter. Blood samples were collected at multiple time points. The primary outcome was LPS mass (measured 24 h after the initiation of treatment). Secondary outcomes included LPS activity, cytokine levels, and clinical outcomes. Results: 20 patients were allocated to each group and analyzed. LPS plasma concentrations were not different between the OXIRIS filter and ST-150 filter groups at H24 (599 pmol/ml of esterified 3-OH fatty acids [450;734] vs 520 [456;835], p = 0.983) or when analyzing all time-points by linear mixed modelling (538 [469;723] vs 507 [434;671] at H26, 576 [513;614] vs 624 [503;724] at H48 and 632 [513;660] vs 586 [538;776] at H72, p = 0.882). No significant between groups differences were found in LPS activity, inflammation markers (IL-6, TNF-α, IL-10, MCP-1), SOFA scores, VIS scores, or 28-day mortality (13 (65%) vs 9 (45%) p = 0.21). There was high variability in LPS concentrations, suggesting heterogeneity in endotoxemia. Conclusions: In patients with cardiogenic shock supported by VA-ECMO and requiring renal replacement therapy, we could not evidence any reduction in LPS blood concentration in patients treated with treatment with OXIRIS filter in comparison to ST-150 filter. Further research is required to confirm these findings and optimize endotoxin removal in this population. Trials Registration: NCT04886180. Registered 10 May 2021.