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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

Sponsored by Centre Hospitalier Universitaire Dijon

About this trial

Last updated 4 years ago

Study ID

NGUYEN 2020-2

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial 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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting