Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).

NCT04201119 | Completed

• 1 other identifier: PI2019_843_0072
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Oxiris membrane is an efficient tool for inflammatory cytokines adsorption. Cardiac surgery is followed by an inflammatory state mimicking sepsis. The investigators hypothesized that cytokine adsorption by Oxiris® membrane can attenuate the inflammatory response and thus decrease the microcirculation impairment that followed cardiac surgery.

Conditions

Surgery; Cardiac Event

Outcome Measures

Primary Outcomes (1)

• Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.

  Day 1

Secondary Outcomes (51)

• Improvement in microcirculation flow with Oxiris® membrane during CPB time at 6 hours after cardiac surgery

  at 6 hours

• Improvement in microcirculation flow with Oxiris® membrane during CPB time at 2 days after cardiac surgery

  at 2 days

• Decrease of myocardial infarction with Oxiris® membrane

  at day 30

• Decrease of stroke with Oxiris® membrane

  at day 30

• Decrease of ischemic mesenteric with Oxiris® membrane

  at day 30

Study Arms (2)

With Oxiris

EXPERIMENTAL

Device: Oxiris

Without Oxiris

NO INTERVENTION

Interventions

Oxiris DEVICE

Oxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1

With Oxiris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with more than 18 years old
• Elective cardiac surgery under CPB with an expected CPB time \> 90 minutes (double valve replacement or valve replacement plus coronary arterial bypass graft (CABG))
• Written informed consent from patient or legal surrogates

You may not qualify if:

• Missing informed consent.
• Planned CPB hypothermia \<32ºC
• Emergency surgery.
• Acute infective endocarditis.
• Immunosuppressive treatment or steroids (prednisone \> 0.5 mg/kg/day or equivalent).
• AIDS with a CD4 count of \< 200/ μl
• Autoimmune disorder.
• Transplant receptor.
• Advanced Chronic Kidney Disease (CKD 4 or 5).
• Renal replacement therapy (RRT) in the last 90 days.
• Documented intolerance to study device.
• Pregnancy.
• Coexisting illness with a high probability of death (inferior to 6 months).

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

Related Publications (2)

• Abou-Arab O, Huette P, Haye G, Guilbart M, Touati G, Diouf M, Beyls C, Dupont H, Mahjoub Y. Effect of the oXiris membrane on microcirculation after cardiac surgery under cardiopulmonary bypass: study protocol for a randomised controlled trial (OXICARD Study). BMJ Open. 2021 Jul 9;11(7):e044424. doi: 10.1136/bmjopen-2020-044424.

  PMID: 34244250 RESULT

• Nguyen M, Alvarez M, Evezard C, Ibrahima A, Huette P, Mahjoub Y, Pais-De-Barros JP, Bouhemad B, Masson D, Gautier T, Guinot PG, Abou-Arab O. Impaired endotoxin inactivation, rather than gut translocation, is associated with organ injury in cardiac surgery with cardiopulmonary bypass: An ancilliary analysis of a randomised control trial. Eur J Anaesthesiol. 2026 Jan 14. doi: 10.1097/EJA.0000000000002350. Online ahead of print.

  PMID: 41532670 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

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: December 13, 2019
• First Posted: December 17, 2019
• Study Start: February 28, 2020
• Primary Completion: November 17, 2023
• Study Completion: August 14, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)