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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-28

Study Completion Date

2024-08-14

Brief Summary

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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.

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Detailed Description

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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

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Surgery Cardiac Event

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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With Oxiris

Group Type EXPERIMENTAL

Oxiris

Intervention Type DEVICE

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

Without Oxiris

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oxiris

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

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No