Trials / Completed
CompletedNCT04886180
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Centre Hospitalier Universitaire Dijon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Oxiris membrane | Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours. |
| 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 |
Timeline
- Start date
- 2021-05-18
- Primary completion
- 2023-03-10
- Completion
- 2023-03-10
- First posted
- 2021-05-13
- Last updated
- 2024-02-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04886180. Inclusion in this directory is not an endorsement.