Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated With Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX

Study Overview
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Brief Summary
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The Oxiris membrane is an AN-69 membrane whose surface is treated with polyethyleneimine (PEI) grafted with heparin. This property allows the removal of lipopolysaccharide and cytokines from the blood. During septic shock, this membrane has shown its effectiveness and made it possible to decrease the doses of vasopressors administered, thus limiting the negative consequences of their use (low mesenteric flow in particular). Moreover, the literature suggests that the use of the Oxiris membrane does not lead to side effects or specific and serious complications, in comparison with conventional extra-renal purification membranes. To our knowledge (Pubmed, clinicaltrial) there are no data in patients in cardiogenic shock assisted by ECLS. The research hypothesis is that the early addition of an Oxiris membrane to the ECLS circuit allows the removal of lipopolysaccharides and pro-inflammatory cytokines, thus controlling the inflammatory cascade and limiting vasoplegia and organ failure.

Official Title
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Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated With Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX

Conditions
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Cardiogenic Shock

Intervention / Treatment
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* Device: Oxiris membrane
* Device: Prismaflex membrane
* Biological: Blood tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Trusted person or relative who has given oral consent or emergency consent Person of legal age Patient receiving ECLS for refractory cardiogenic shock requiring continuous renal replacement therapy Included within 12 hours of ECLS initiation Exclusion Criteria: Person not affiliated to national health insurance Person under legal protection (curatorship, guardianship) Person under court order Pregnant or breastfeeding woman Minor Severe hemorrhage under ECLS

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Device: Oxiris membrane<br>* Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours.<br>Biological: Blood tests<br>* Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement<br>|
| Active Comparator: Control<br> | Device: Prismaflex membrane<br>* Treatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours.<br>Biological: Blood tests<br>* Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of lipopolysaccharides |  | 24 hours after addition of the membrane |