NCT04886180: ECMORIX

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

Completed NA Last updated 20 February 2024

What this trial tests

NA trial testing Oxiris membrane in Cardiogenic Shock in 40 participants. Completed in 10 March 2023.

Timeline

18 May 2021

Primary endpoint
10 March 2023

10 March 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	18 May 2021
Primary completion	10 March 2023
Estimated completion	10 March 2023
Sites	1 location across France

Drugs / interventions tested

• Oxiris membrane
• Prismaflex membrane
• Blood tests — full drug profile →

Conditions studied

• Cardiogenic Shock — all drugs for Cardiogenic Shock →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

18 and older, any sex, with Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endotoxin in Sepsis: Methods for LPS Detection and the Use of Omics Techniques.
   Virzì GM, Mattiotti M, de Cal M, Ronco C, et al · · 2022 · cited 45× · PMID 36611371 · DOI 10.3390/diagnostics13010079
2. Effect of Continuous Renal Replacement Therapy with the oXiris Hemofilter on Critically Ill Patients: A Narrative Review.
   Li Y, Sun P, Chang K, Yang M, et al · · 2022 · cited 26× · PMID 36431196 · DOI 10.3390/jcm11226719
3. Extending the 'host response' paradigm from sepsis to cardiogenic shock: evidence, limitations and opportunities.
   Buckel M, Maclean P, Knight JC, Lawler PR, et al · · 2023 · cited 19× · PMID 38012789 · DOI 10.1186/s13054-023-04752-8
4. Evaluation of the Oxiris Membrane in Cardiogenic Shock Requiring Extracorporeal Membrane Oxygenation Support: Study Protocol for a Single Center, Single-Blind, Randomized Controlled Trial.
   Andrei S, Nguyen M, Berthoud V, Morgant MC, et al · · 2021 · cited 8× · PMID 34708091 · DOI 10.3389/fcvm.2021.738496
5. Endotoxin removal by the OXIRIS filter for cardiogenic shock requiring veno-arterial extra-corporeal life support: the ECMORIX randomized controlled trial.
   Nguyen M, Alvarez M, Evezard C, Berthoud V, et al · · 2025 · cited 1× · PMID 40627256 · DOI 10.1186/s13613-025-01499-z
6. Interleukin-6 in Cardiogenic Shock.
   Fazzini L, Golino M, Moroni F, Castrichini M, et al · · 2025 · PMID 40884675 · DOI 10.1007/s11886-025-02273-0