The Effects of oXiris on Systemic Inflammation, Endothelial Dysfunction and Volume Control in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient volume status assessment in perioperative period
研究概览
简要总结
CS-AKI occurring in 20% to 70% of cases depending of the type of cardiac surgery. The systemic inflammatory response is often observed and associated with increased risk of AKI. Cardiopulmonary bypass (CPB) induces a complex inflammatory response that has a multifactorial pathogenesis. The inflammatory response is triggered by exposure of the blood to artificial surfaces during extracorporeal circulation, ischemia/reperfusion injuries, translocation of gram-negative bacteria from the intestinal tract, small amounts of LPS in IV solutions. SIRS during CPB with high levels of inflammatory mediators, active complement proteins and LPS provoke endothelial dysfunction- retraction of endothelial cells with increasing vascular permeability and thrombogenic activity, also inflammatory mediators activate leukocytes and they enhance vascular permeability by affecting endothelial cells and vascular basement membrane. The systemic inflammation and endothelial dysfunction are the basis for multiple organ dysfunction syndrome. Vascular integrity damage during cardiac surgery entail redistribution of fluids with interstitial fluid accumulation and require accurate volume control (pertinent removal of "CPB priming volume"), especially in patients with CKD (low GFR) with high risks of AKI.
详细描述
Specific details of Treatment/Intervention: (prescription and/or therapy, devices, equipment, solutions, product to be used in conducting study:
To apply Prismaflex system with oXiris membrane after cardiopulmonary bypass in SCUF modality for CPB priming volume elimination.
Duration of procedure: 6 hours Blood flow:150-200 ml/min Anticoagulation: no additional heparinization.
According to the features of oXiris membrane:
- Cytokines, complement, endotoxin adsorptive capacity.
- Capability of accurate fluid balance management after cardiac surgery and CPB.
- Reduced demand of anticoagulation therapy for CRRT in patients with high risk of bleeding.
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
- Double (Participant, Investigator)
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
- •elective cardiac surgery patients undergoing CPB (>60 minutes) with valve replacement and CABG.
排除标准
- •Immunosuppressive therapy, CKD 4 and 5 stages, RRT in last 90 days, pregnancy, autoimmune disease, allergy to heparin.
研究组 & 干预措施
patients undergoing CRRT with oXiris membrane
Elective cardiac surgery patients undergoing CPB we will range in 2 groups: I- with Prismaflex set oXiris (SCUF) after CPB, II- standard protocol.
Indications for CRRT (SCUF) with oXiris after ICU admission:
- Signs of pulmonary edema after cardiac surgery, verified with X-ray control.
Or high risk of pulmonary edema after cardiac surgery:
- Fluid overload ≥ 10%, measured with equation (%fluid overload= ((total fluid in- total fluid out)/admission body weight*100)
- CVP (central venous pressure) ˃ 12 mm H2O.
- PAWP (pulmonary arterial wedge pressure) ˃ 12 mm Hg, measured by Swan-Ganz catheter.
In this arm the treatment of fluid overload will be provided via SCUF with oxiris membrane
干预措施: oXiris membrane (Device)
standard protocol
Elective cardiac surgery patients undergoing CPB we will range in 2 groups: I- with Prismaflex set oXiris (SCUF) after CPB, II- standard protocol.
Indications for CRRT (SCUF) with oXiris after ICU admission:
- Signs of pulmonary edema after cardiac surgery, verified with X-ray control.
Or high risk of pulmonary edema after cardiac surgery:
- Fluid overload ≥ 10%, measured with equation (%fluid overload= ((total fluid in- total fluid out)/admission body weight*100)
- CVP (central venous pressure) ˃ 12 mm H2O.
- PAWP (pulmonary arterial wedge pressure) ˃ 12 mm Hg, measured by Swan-Ganz catheter.
In this arm the management of fluid overload will be provided via diuretics or IHD (in condition diuretics treatment resistance)
结局指标
主要结局
Patient volume status assessment in perioperative period
时间窗: in 24 hours
To compare volume status in two arms based on CVP mmH2O and PAWP mmHg measurements
次要结局
- survival after cardiac surgery(in 90 day)
- 'ICU and hospital length of stay after cardiac surgery.(in 28 days)