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 (ECMORIX)
Primary Purpose
Cardiogenic Shock
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oxiris membrane
Prismaflex membrane
Blood tests
Sponsored by
About this trial
This is an interventional treatment trial for Cardiogenic Shock
Eligibility Criteria
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
Sites / Locations
- Chu Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Outcomes
Primary Outcome Measures
Plasma concentration of lipopolysaccharides
Secondary Outcome Measures
Full Information
NCT ID
NCT04886180
First Posted
May 10, 2021
Last Updated
June 29, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT04886180
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Oxiris membrane
Intervention Description
Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours.
Intervention Type
Device
Intervention Name(s)
Prismaflex membrane
Intervention Description
Treatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours.
Intervention Type
Biological
Intervention Name(s)
Blood tests
Intervention Description
Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement
Primary Outcome Measure Information:
Title
Plasma concentration of lipopolysaccharides
Time Frame
24 hours after addition of the membrane
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maxime NGUYEN
Phone
03 80 29 35 28
Email
maxime.nguyen-soenen@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime NGUYEN
Phone
03 80 29 35 28
Email
maxime.nguyen-soenen@chu-dijon.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
34708091
Citation
Andrei S, Nguyen M, Berthoud V, Morgant MC, Bouhemad B, Guinot PG; ECMORIX Study Group. Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 11;8:738496. doi: 10.3389/fcvm.2021.738496. eCollection 2021.
Results Reference
derived
Learn more about this 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
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