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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
Sponsor: Centre Hospitalier Universitaire Dijon
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2021-05-18
Completion Date
2023-03-10
Last Updated
2026-07-16
Healthy Volunteers
No
Conditions
Interventions
Oxiris membrane
Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours.
Prismaflex membrane
Treatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours.
Blood tests
Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement
Locations (1)
Chu Dijon Bourgogne
Dijon, France