NCT04201119已完成不适用
Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.
时间窗: Day 1
次要结局
- Decrease of acute kidney injury with Oxiris® membrane(at day 30)
- Decrease of In-hospital mortality with Oxiris® membrane(30 days)
- Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time(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(30 days)
- 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(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)
- 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(at day 30)
- Decrease of stroke with Oxiris® membrane(at day 30)
- Decrease of ischemic mesenteric with Oxiris® membrane(at day 30)
- Decrease of cardiac arrest with Oxiris® membrane(at day 30)
- Decrease of sudden death with Oxiris® membrane(at day 30)
- Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane(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 2 days after surgery with Oxiris® membrane(two days)
- Decrease of ischemic mesenteric with Oxiris® membrane(at day 30)
- Decrease of cardiac arrest with Oxiris® membrane(at day 30)
- 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(at day 30)
- Decrease of stroke with Oxiris® membrane(at day 30)
- Decrease of sudden death with Oxiris® membrane(at day 30)
- Decrease of acute kidney injury with Oxiris® membrane(at day 30)
- Decrease of In-hospital mortality with Oxiris® membrane(30 days)
- Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time(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(30 days)
- Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane(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 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(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)
研究者
研究点 (2)
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