Clinical trial NCT04201119: Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).
Official title: Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Cardiac Event
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.
timeFrame: Day 1
Secondary outcomes:
measure: Improvement in microcirculation flow with Oxiris® membrane during CPB time at 6 hours after cardiac surgery
timeFrame: at 6 hours
measure: Improvement in microcirculation flow with Oxiris® membrane during CPB time at 2 days after cardiac surgery
timeFrame: at 2 days
measure: Decrease of myocardial infarction with Oxiris® membrane
timeFrame: at day 30
measure: Decrease of stroke with Oxiris® membrane
timeFrame: at day 30
measure: Decrease of ischemic mesenteric with Oxiris® membrane
timeFrame: at day 30
measure: Decrease of cardiac arrest with Oxiris® membrane
timeFrame: at day 30
measure: Decrease of sudden death with Oxiris® membrane
timeFrame: at day 30
measure: Decrease of acute kidney injury with Oxiris® membrane
timeFrame: at day 30
measure: Decrease of In-hospital mortality with Oxiris® membrane
timeFrame: 30 days
measure: Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time
timeFrame: day 30
measure: Decrease of Requirement for renal replacement therapy events with Oxiris® membrane
timeFrame: 30 days
measure: Sepsis-related Organ Failure Assessment (SOFA) score with Oxiris® membrane
timeFrame: 30 days
measure: Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane
timeFrame: 30 days
measure: decrease of day number in ICU with Oxiris® membrane
timeFrame: 30 days
measure: decrease of hospital stay in days with Oxiris® membrane
timeFrame: 30 days
measure: Decrease of syndecan-1 expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Decrease of syndecan-1 expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: day 1
measure: Decrease of syndecan-1 expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
timeFrame: day 2
measure: Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Decrease of heparan-sulfate expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: day 1
measure: Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
timeFrame: day 2
measure: Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane
timeFrame: day 1
measure: Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
timeFrame: day 2
measure: Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
timeFrame: two days
measure: Variation of endothelin concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of endothelin concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of endothelin concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
timeFrame: 2 days
measure: Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
timeFrame: two days
measure: Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
timeFrame: 2 days
measure: Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
timeFrame: two days
measure: Variation of VEGF concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of VEGF concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of VEGF concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
timeFrame: two days
measure: Variation of myocardial strain from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of myocardial strain from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of myocardial strain from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
timeFrame: two days
measure: Variation of diastolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of diastolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of diastolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
timeFrame: 2 days
measure: Variation of systolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
timeFrame: 6 hours
measure: Variation of systolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
timeFrame: one day
measure: Variation of systolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
timeFrame: 2 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
citation: Abou-Arab O, Huette P, Haye G, Guilbart M, Touati G, Diouf M, Beyls C, Dupont H, Mahjoub Y. Effect of the oXiris membrane on microcirculation after cardiac surgery under cardiopulmonary bypass: study protocol for a randomised controlled trial (OXICARD Study). BMJ Open. 2021 Jul 9;11(7):e044424. doi: 10.1136/bmjopen-2020-044424.