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Completed

NCT Number: NCT04886180

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

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.

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Dijon Bourgogne

Dijon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oXiris membrane

Device

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

Prismaflex membrane

Device

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

Blood tests

Biological

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

Primary outcomes

  1. Plasma concentration of lipopolysaccharides

    Time frame: 24 hours after addition of the membrane

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: ECMORIX

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 13, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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