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

Last updated: April 11, 2023
Sponsor: Centre Hospitalier Universitaire, Amiens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Treatment

N/A

Clinical Study ID

NCT04201119
PI2019_843_0072
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • 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.
  • Inclusion in other ongoing study within the last 30 days.
  • Pregnancy.
  • Coexisting illness with a high probability of death (inferior to 6 months).

Study Design

Total Participants: 70
Study Start date:
February 28, 2020
Estimated Completion Date:
March 30, 2024

Study Description

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.

Connect with a study center

  • CHU Amiens-Picardie

    Amiens, 80054
    France

    Active - Recruiting

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