CHU Amiens-Picardie
Amiens, 80054, France
Completed
NCT Number: NCT04201119
Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Oxiris
DeviceOxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1
Primary outcomes
-
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
Secondary outcomes
-
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
Time frame: 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 stroke with Oxiris® membrane
Time frame: 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
Time frame: 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 cardiac arrest with Oxiris® membrane
Time frame: 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
Time frame: 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 acute kidney injury with Oxiris® membrane
Time frame: 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
Time frame: 30 days
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
Time frame: day 30
catecholamine are dobutamine and norepinephrine
-
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
Time frame: 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.
-
Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane
Time frame: 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 patients
-
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
Time frame: 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
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
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Other
Registry information
Acronym: OXICARD
Important dates
- Study start
- 2020
- Primary completion
- 2023
- Study completion
- 2024
- First posted
- Dec 17, 2019
- Registry last updated
- Sep 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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