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

Centre Hospitalier Universitaire, Amiens

Status

Completed

Conditions

Surgery

Cardiac Event

Treatments

Device: Oxiris

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04201119

PI2019_843_0072

Details and patient eligibility

About

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.

Full description

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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).