Cardiogenic ShockECMORIXNCT04886180
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
A study testing Oxiris membrane, Prismaflex membrane and Blood tests in people with Cardiogenic Shock, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Oxiris membrane, Prismaflex membrane and Blood tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2021to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Cardiogenic Shock
- Being tested
- Oxiris membrane, Prismaflex membrane, Blood tests
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxiris membraneDevice
Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours.
Prismaflex membraneDevice
Treatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours.
Blood testsBiological
Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Device: Oxiris membrane; Biological: Blood tests |
| Control | Active comparator | Not described Receives: Device: Prismaflex membrane; Biological: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of lipopolysaccharides
Measured: 24 hours after addition of the membrane
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start18 May 2021
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886180
- Sponsor's protocol ID
- NGUYEN 2020-2
- Acronym
- ECMORIX
- Status last verified
- Jul 2026
- First submitted
- 10 May 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40627256Andrei 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.
PubMed 34708091
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04886180
- Acronym / sponsor ID
- ECMORIX / NGUYEN 2020-2
- Conditions
- Cardiogenic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Oxiris membrane, Biological: Blood tests |
| Control | Active comparator | Device: Prismaflex membrane, Biological: Blood tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Person not affiliated to national health insurance
- Person under legal protection (curatorship, guardianship)
- Person under court order
- Pregnant or breastfeeding woman
- Minor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxiris membraneHemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours. | Device | Experimental |
| Prismaflex membraneTreatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours. | Device | Control |
| Blood testsBlood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement | Biological | Control, Experimental |
Primary outcome
Plasma concentration of lipopolysaccharides
Time frame: 24 hours after addition of the membrane
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Results publication: PubMed 40627256Nguyen 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.
- Derived from this study: PubMed 34708091Andrei 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxiris membrane, Prismaflex membrane and Blood tests in people with Cardiogenic Shock, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of lipopolysaccharides (time frame: 24 hours after addition of the membrane). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886180, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.