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Background <p>A systemic inflammatory response can contribute to poor outcomes in an advanced stage of cardiogenic shock (CS). We investigated the efficacy of extracorporeal endotoxin and cytokine adsorption using oXiris in patients with CS undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO).</p> Methods <p>In this prospective, single-center, randomized, open-label pilot trial, 40 patients with CS who were undergoing VA-ECMO were randomly assigned to receive either oXiris for 24&#xa0;h (<i>n</i> = 20) or usual care (<i>n</i> = 20). The primary endpoint was endotoxin levels at 48&#xa0;h. Secondary endpoints included changes in inflammatory cytokines, vasoactive-inotropic score (VIS), ECMO weaning success, and in-hospital and 30-day mortality.</p> Results <p>The median endotoxin levels at 48&#xa0;h were 0.5 (IQR 0.4–1.0) in the oXiris group and 0.4 (IQR 0.2–0.5) in the control group, with no significant difference between them (<i>P</i> = 0.097). The oXiris group showed significant temporal reductions in GDF-15 and IL-6 levels, with IL-6 revealing significant reductions from baseline to 24&#xa0;h (<i>P</i> = 0.020) and from baseline to 7 days (<i>P</i> = 0.003). VIS decreased significantly from baseline to 48&#xa0;h (-13.63, 95% CI: -20.90 – -6.34, <i>P</i> &lt; 0.001) and 7 days (-12.19, 95% CI: -21.0 – -3.31, <i>P</i> = 0.007) in the oXiris group, but intergroup differences were insignificant. ECMO weaning success, duration of ECMO support, and mortality rates were similar between the groups.</p> Conclusion <p>In this pilot study conducted on CS patients requiring VA-ECMO, oXiris treatment did not significantly reduce endotoxin levels or improve patient centered clinical outcomes.</p> Trial registration <p>NCT05642273, registered 8 December 2022.</p>

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The effects of extracorporeal blood purification (oXiris®) in patients with cardiogenic shock who require VA-ECMO (CLEAN ECMO): a prospective, open-label, randomized controlled pilot study

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  • 发表日期：

    2025年6月20日

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  • Ryoung-Eun Ko,
  • Ki Hong Choi,
  • Kyungho Lee,
  • Junseok Jeon,
  • Hye Ryoun Jang,
  • Chi Ryang Chung,
  • Yang Hyun Cho,
  • Taek Kyu Park,
  • Joo Myung Lee,
  • Young Bin Song,
  • Joo-Yong Hahn,
  • Seung-Hyuk Choi,
  • Hyeon-Cheol Gwon,
  • Jeong Hoon Yang

摘要

Background

A systemic inflammatory response can contribute to poor outcomes in an advanced stage of cardiogenic shock (CS). We investigated the efficacy of extracorporeal endotoxin and cytokine adsorption using oXiris in patients with CS undergoing venoarterial extracorporeal membrane oxygenation (VA-ECMO).

Methods

In this prospective, single-center, randomized, open-label pilot trial, 40 patients with CS who were undergoing VA-ECMO were randomly assigned to receive either oXiris for 24 h (n = 20) or usual care (n = 20). The primary endpoint was endotoxin levels at 48 h. Secondary endpoints included changes in inflammatory cytokines, vasoactive-inotropic score (VIS), ECMO weaning success, and in-hospital and 30-day mortality.

Results

The median endotoxin levels at 48 h were 0.5 (IQR 0.4–1.0) in the oXiris group and 0.4 (IQR 0.2–0.5) in the control group, with no significant difference between them (P = 0.097). The oXiris group showed significant temporal reductions in GDF-15 and IL-6 levels, with IL-6 revealing significant reductions from baseline to 24 h (P = 0.020) and from baseline to 7 days (P = 0.003). VIS decreased significantly from baseline to 48 h (-13.63, 95% CI: -20.90 – -6.34, P < 0.001) and 7 days (-12.19, 95% CI: -21.0 – -3.31, P = 0.007) in the oXiris group, but intergroup differences were insignificant. ECMO weaning success, duration of ECMO support, and mortality rates were similar between the groups.

Conclusion

In this pilot study conducted on CS patients requiring VA-ECMO, oXiris treatment did not significantly reduce endotoxin levels or improve patient centered clinical outcomes.

Trial registration

NCT05642273, registered 8 December 2022.