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

Not Applicable

Completed

• Conditions: Cardiogenic Shock
• Interventions: Device: Prismaflex membrane; Device: Oxiris membrane; Biological: Blood tests

• Registration Number: NCT04886180
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-10
• Study First Posted: 2021-05-13
• Study Start: 2021-05-18
• Primary Completion: 2023-03-10
• Study Completion: 2023-03-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Blood tests	-
Control	Prismaflex membrane	-
Control	Blood tests	-
Experimental	Oxiris membrane	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration of lipopolysaccharides	24 hours after addition of the membrane

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France