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

Study Overview
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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.

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.

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

Conditions
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Surgery, Cardiac Event

Intervention / Treatment
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* Device: Oxiris


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With Oxiris<br> | Device: Oxiris<br>* Oxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1<br>|
| No Intervention: Without Oxiris<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality | at day 30 | 
| Decrease of stroke with Oxiris® membrane | Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality | at day 30 | 
| Decrease of ischemic mesenteric with Oxiris® membrane | Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality | at day 30 | 
| Decrease of cardiac arrest with Oxiris® membrane | Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality | at day 30 | 
| Decrease of sudden death with Oxiris® membrane | Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality | at day 30 | 
| Decrease of acute kidney injury with Oxiris® membrane | Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality | at day 30 | 
| Decrease of In-hospital mortality with Oxiris® membrane | Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality | 30 days | 
| Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time | catecholamine are dobutamine and norepinephrine | day 30 | 
| Decrease of Requirement for renal replacement therapy events with Oxiris® membrane |  | 30 days | 
| Sepsis-related Organ Failure Assessment (SOFA) score with Oxiris® membrane | The quick SOFA score (qSOFA) assists health care providers in estimating the risk of morbidity and mortality due to sepsis. The score ranges from 0 to 3 points. The presence of 2 or more qSOFA points near the onset of infection was associated with a greater risk of death or prolonged intensive care unit stay. | 30 days | 
| Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane | SAPS II was designed to measure the severity of disease for patients admitted to Intensive care units aged 18 or more. 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%. No new score can be calculated during the stay. If a patient is discharged from the ICU and readmitted, a new SAPS II score can be calculated. This scoring system is mostly used to: describe the morbidity of a patient when comparing the outcome with other patients. describe the morbidity of a group of patients when comparing the outcome with another group of patients | 30 days | 
| decrease of day number in ICU with Oxiris® membrane |  | 30 days | 
| decrease of hospital stay in days with Oxiris® membrane |  | 30 days | 
| Decrease of syndecan-1 expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Decrease of syndecan-1 expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | day 1 | 
| Decrease of syndecan-1 expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane |  | day 2 | 
| Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Decrease of heparan-sulfate expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | day 1 | 
| Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane |  | day 2 | 
| Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane |  | day 1 | 
| Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane |  | day 2 | 
| Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane |  | one day | 
| Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane |  | two days | 
| Variation of endothelin concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of endothelin concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane | - Comparison endothelin from baseline and at the end of cardiac surgery, H6, day 1 and day2 | one day | 
| Variation of endothelin concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane |  | 2 days | 
| Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | one day | 
| Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane |  | two days | 
| Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | one day | 
| Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane |  | 2 days | 
| Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | one day | 
| Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane |  | two days | 
| Variation of VEGF concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of VEGF concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | one day | 
| Variation of VEGF concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane |  | two days | 
| Variation of myocardial strain from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of myocardial strain from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | one day | 
| Variation of myocardial strain from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane |  | two days | 
| Variation of diastolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of diastolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | one day | 
| Variation of diastolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane |  | 2 days | 
| Variation of systolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane |  | 6 hours | 
| Variation of systolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane |  | one day | 
| Variation of systolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane |  | 2 days |