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

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04886180

Acronym

ECMORIX

Enrollment

Registered

2021-05-13

Start date

2021-05-18

Completion date

2023-03-10

Last updated

2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic Shock

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.

Interventions

DEVICEOxiris membrane

Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours.

DEVICEPrismaflex membrane

Treatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours.

BIOLOGICALBlood tests

Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Plasma concentration of lipopolysaccharides	24 hours after addition of the membrane

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026