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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Plasma concentration of lipopolysaccharides
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Severe hemorrhage under ECLS
Arms & Interventions
Control
Intervention: Prismaflex membrane (Device)
Control
Intervention: Blood tests (Biological)
Experimental
Intervention: Oxiris membrane (Device)
Experimental
Intervention: Blood tests (Biological)
Outcomes
Primary Outcomes
Plasma concentration of lipopolysaccharides
Time Frame: 24 hours after addition of the membrane
Secondary Outcomes
No secondary outcomes reported