Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).
- Conditions
- Cardiac EventSurgery
- Interventions
- Device: Oxiris
- Registration Number
- NCT04201119
- Lead Sponsor
- Centre Hospitalier Universitaire, Amiens
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description With Oxiris Oxiris -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Variation of inflammatory cytokine 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 two days after surgery with Oxiris® membrane two 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 VEGF concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane one day Improvement in microcirculation flow with Oxiris® membrane during CPB time at 6 hours after cardiac surgery at 6 hours Decrease of cardiac arrest with Oxiris® membrane at day 30 Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Decrease of In-hospital mortality with Oxiris® membrane 30 days Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane 30 days 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 patientsImprovement 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 at day 30 Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Decrease of ischemic mesenteric with Oxiris® membrane at day 30 Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Decrease of sudden death with Oxiris® membrane at day 30 Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Decrease of Requirement for renal replacement therapy events 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 acute kidney injury with Oxiris® membrane at day 30 Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time day 30 catecholamine are dobutamine and norepinephrine
Sepsis-related Organ Failure Assessment (SOFA) score with Oxiris® membrane 30 days 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.Decrease of syndecan-1 expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane day 2 Decrease of stroke with Oxiris® membrane at day 30 Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
decrease of day number in ICU with Oxiris® membrane 30 days decrease of hospital stay in days with Oxiris® membrane 30 days Decrease of heparan-sulfate expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane day 1 Decrease of hyaluronic acid 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 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 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 angiopoietin 2 concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane 2 days Variation of myocardial strain from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane two days Variation of systolic function 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 6 hours after surgery with Oxiris® membrane 6 hours 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 1 day after surgery with Oxiris® membrane day 1 Variation of endothelin concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane one day - Comparison endothelin from baseline and at the end of cardiac surgery, H6, day 1 and day2
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 one day after surgery with Oxiris® membrane one day 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 two days after surgery with Oxiris® membrane two days Variation of diastolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane 2 days Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane one day Variation of angiopoietin 1 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 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 Tie2 soluble receptor 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 systolic function 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 one day after surgery with Oxiris® membrane one day 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 systolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane 2 days
Trial Locations
- Locations (1)
CHU Amiens-Picardie
🇫🇷Amiens, France