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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Oxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1
CHU Amiens-Picardie
Amiens, France
Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.
Time frame: Day 1
Improvement in microcirculation flow with Oxiris® membrane during CPB time at 6 hours after cardiac surgery
Time frame: at 6 hours
Improvement in microcirculation flow with Oxiris® membrane during CPB time at 2 days after cardiac surgery
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at day 30
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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
Time frame: 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
Time frame: 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
Time frame: 30 days
Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time
catecholamine are dobutamine and norepinephrine
Time frame: day 30
Decrease of Requirement for renal replacement therapy events with Oxiris® membrane
Time frame: 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.
Time frame: 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
Time frame: 30 days
decrease of day number in ICU with Oxiris® membrane
Time frame: 30 days
decrease of hospital stay in days with Oxiris® membrane
Time frame: 30 days
Decrease of syndecan-1 expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Decrease of syndecan-1 expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: day 1
Decrease of syndecan-1 expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: day 2
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: day 1
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: day 2
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane
Time frame: day 1
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: day 2
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane
Time frame: one day
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: two days
Variation of endothelin concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 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
Time frame: one day
Variation of endothelin concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: 2 days
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Time frame: two days
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: 2 days
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Time frame: two days
Variation of VEGF concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of VEGF concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of VEGF concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Time frame: two days
Variation of myocardial strain from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of myocardial strain from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of myocardial strain from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Time frame: two days
Variation of diastolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of diastolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of diastolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: 2 days
Variation of systolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of systolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of systolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: 2 days