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NCT04886180 Clinical Trial

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

Cardiogenic Shock Clinical Trial

— ECMORIX  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04886180
Other study ID # NGUYEN 2020-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 18, 2021
Est. completion date March 10, 2023

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 10, 2023
Est. primary completion date March 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Oxiris membrane
Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours.
• Prismaflex membrane
Treatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours.
Biological:
• Blood tests
Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement

Locations
Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentration of lipopolysaccharides 24 hours after addition of the membrane
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