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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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04886180
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
36.5
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Oxiris membrane
  • Device: Prismaflex membrane
  • Biological: Blood tests
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 18, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

Device: Oxiris membrane
Hemofiltration treatment with Oxiris 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
Active Comparator: Control

Device: 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

Outcome Measures

Primary Outcome Measures

  1. Plasma concentration of lipopolysaccharides [24 hours after addition of the membrane]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourgogne Dijon France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT04886180
Other Study ID Numbers:
  • NGUYEN 2020-2
First Posted:
May 13, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Shock, Cardiogenic
Shock
Ischemia

Study Results

No Results Posted as of Jun 30, 2021