Trial reportCritical care (London, England)2025
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.
Trial report in Critical care (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05642273 (The Effects of extraCorporeal bLood Purification), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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The trial behind it
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The Effects of extraCorporeal bLood Purification (oXiris ®) in patiEnts With cArdiogeNic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Hemoperfusion during extracorporeal membrane oxygenation: an updated systematic review and meta-analysis of 8,151 patients.Critical care (London, England) · 2026Pooled it
- Impact of adsorptive CRRT membranes on vancomycin pharmacokinetics in critically ill patients.Renal failure · 2026Review
- Clinical applications of oXiris membranes: Targeting inflammation and renal dysfunction in ICU patients.Journal of intensive medicine · 2026Review
- Mechanistic success and clinical neutrality: lessons from the OXICARD trial.Journal of thoracic disease · 2026Article
- oXiris in severe cardiogenic shock with endotoxemia: interpreting the negative findings of the CLEAN-ECMO trial.Critical care (London, England) · 2026Article
- Extracorporeal Cytokine Adsorption in Acute Cardiovascular Care: Pathophysiological Insights and Clinical Perspectives.Biomedicines · 2026Review
- Selective Cytopheretic Device Therapy in the Context of Extracorporeal Membrane Oxygenation.Medicina (Kaunas, Lithuania) · 2025Review
- When blood purification meets cardiogenic shock: exploring new perspectives on inflammatory clearance from CLEAN ECMO's null results.Critical care (London, England) · 2025Article
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Authors and funding
14 authors.
Funding
Abstract
backgroundA 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).
methodsIn 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.
resultsThe 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.
conclusionIn 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 registrationNCT05642273, registered 8 December 2022.
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