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

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Cardiogenic Shock

Treatments: Device: Prismaflex membrane; Biological: Blood tests; Device: Oxiris membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT04886180

NGUYEN 2020-2

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Experimental

Experimental group

Treatment:

Device: Oxiris membrane

Biological: Blood tests

Control

Active Comparator group

Treatment:

Device: Prismaflex membrane

Biological: Blood tests