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Randomized Controlled Trial
. 2025 Jun 20;29(1):255.
doi: 10.1186/s13054-025-05495-4.

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

Ryoung-Eun Ko  1 , Ki Hong Choi  2 , Kyungho Lee  3 , Junseok Jeon  3 , Hye Ryoun Jang  3 , Chi Ryang Chung  1 , Yang Hyun Cho  4 , Taek Kyu Park  2 , Joo Myung Lee  2 , Young Bin Song  2 , Joo-Yong Hahn  2 , Seung-Hyuk Choi  2 , Hyeon-Cheol Gwon  2 , Jeong Hoon Yang  5   6
Affiliations
Randomized Controlled Trial

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

Ryoung-Eun Ko et al. Crit Care. .

Abstract

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.

Keywords: Cardiogenic shock; Cytokine; Endotoxin; Extracorporeal membrane oxygenation; Inflammatory marker.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The research was conducted according to the Declaration of Helsinki, and the study protocol was approved by the institutional review board of Samsung Medical Center (No. 2022-09-082) and registered at ClinicalTrials.gov (NCT05642273, registered 8 December 2022). All participants or their representatives provided written informed consent to participate. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of participants. ECMO, extracorporeal membrane oxygenation
Fig. 2
Fig. 2
Plasma cytokine, endotoxin, and lactate levels within 7 days of randomization. Medians and interquartile ranges in the control group and the oXiris group within 7 days of randomization. Red = oXiris group, Blue = control group. IL interleukin, GDF growth differentiation factor. *indicates statistical significance. The oXiris group showed significant reductions in IL-6 levels compared to the control group at 24 h (coefficient − 369; 95% CI, −681 to −57; p = 0.020) and 7 days (coefficient − 379; 95% CI, −659 to −134.8; p = 0.003). Additionally, a significant reduction in GDF-15 levels was observed at 48 h (coefficient − 3,574; 95% CI, −8,818 to 1,671; p = 0.018)
Fig. 3
Fig. 3
Hemodynamic changes within 7 days of randomization. Median and interquartile range in the control group and the oXiris group within 7 days of randomization. Red = oXiris group, Blue = control group. IL interleukin, GDF growth differentiation factor
See this image and copyright information in PMC

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