NCT04886180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 18, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

May 10, 2021

Last Update Submit

February 19, 2024

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

  • Plasma concentration of lipopolysaccharides

    24 hours after addition of the membrane

Study Arms (2)

Experimental

EXPERIMENTAL
Device: Oxiris membraneBiological: Blood tests

Control

ACTIVE COMPARATOR
Device: Prismaflex membraneBiological: Blood tests

Interventions

Oxiris membraneDEVICE

Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours.

Experimental
Prismaflex membraneDEVICE

Treatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours.

Control
Blood testsBIOLOGICAL

Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement

ControlExperimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

Location

Related Publications (2)

  • Nguyen M, Alvarez M, Evezard C, Berthoud V, Leleu D, Pais-De-Barros JP, Bouchot O, Abou-Arab O, Bouhemad B, Masson D, Gautier T, Guinot PG. Endotoxin removal by the OXIRIS filter for cardiogenic shock requiring veno-arterial extra-corporeal life support: the ECMORIX randomized controlled trial. Ann Intensive Care. 2025 Jul 8;15(1):92. doi: 10.1186/s13613-025-01499-z.

    PMID: 40627256DERIVED

  • 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.

    PMID: 34708091DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 13, 2021

Study Start

May 18, 2021

Primary Completion

March 10, 2023

Study Completion

March 10, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

FR(1)