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

  • STATUS
    Recruiting
  • End date
    Jun 11, 2024
  • participants needed
    40
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 11 July 2021

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.

Details
Condition Cardiogenic shock
Treatment blood tests, oXiris membrane, Prismaflex membrane
Clinical Study IdentifierNCT04886180
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

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
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