Clinical Trial to Evaluate Facticity and Security for the Use of an Increased Adsorption Capacity Membrane (oXiris®) During Cardiopulmonary Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety with the use of CPB. Number of complications reported.
研究概览
简要总结
Patients whom require cardiopulmonary bypass (CPB) during surgery present systemic inflammatory response syndrome (SIRS) due to blood cell activation and cytokine release to circulation. SIRS can lead to organ dysfunction due to hemodynamic compromise (vasodilatation plus leak syndrome) and/or cytokine mediated cell injury. Renal dysfunction is a major adverse complication after CPB surgery. Investigators hypothesize that the use of an increased adsorption membrane (OXIRIS®) during CPB is safe and presents low technical complexity. The safe use of OXIRIS® will reduce cytokine circulatory levels therefore decreasing SIRS and its systemic effects specially those concerning renal function. Therefore, patients receiving (OXIRIS®) could potentially present less cardiac surgery-associated acute kidney injury (CSA-AKI), and lower intensive care unit (ICU) and hospital length of stay.
详细描述
The oXiris® set connection to CPB
- The PrismafleX eXeed™ II (Baxter) system control unit will be used to deliver CRRT and thus connected to the CPB circuit through the oXiris® set lines.
- Priming. For oXiris® set priming use 2 L of normal saline according to the software instructions.
- Connection. Using a three-way stopcock, oXiris® set must be connected to the arterial line just after the oxygenator to derive blood into the oXiris® set and then returned into the venous reservoir through the return line. No additional vascular access will be required to deliver treatments.
- Modality. The Slow Continuous Ultrafiltration modality (SCUF modality) must be selected with no pre-set ultrafiltration rate (ultrafiltration rate: 0 ml/hr). A blood flow between 200-300 mL/min was set in the PrismafleX eXeed™ II (blood was derived through the arterial positive pressure line just after the oxygenator) to be delivered into the oXiris® set and then returned into the venous reservoir through the return line.
- All treatments should be delivered after reaching full-flow CPB.
- CRRT flow, pressure and alarms will be controlled in the PrismafleX eXeed™ II screen, independently from CPB circuit.
- If CPB is stopped for any reason, then PrismafleX eXeed™ II should be stopped temporarily to avoid alarm warning and/or any harm to the patient.
- No additional anticoagulation method will be needed besides the systemic anticoagulation required for the cardiopulmonary bypass pumping.
- The return line clamp (blue clamp) should be adjusted to reach a slight positive return pressure in order to avoid low-pressure alarm warning.
PrismafleX eXeed™ II weaning instructions. 5-10 min before the end of CPB, start the blood-return procedure into the venous reservoir of the CPB using 1 L of normal saline. Connect the solution into the three-way stopcock. Subsequently, set PrismafleX eXeed™ II flow in 80-100 ml/min. Select STOP in the PrismafleX eXeed™ II screen. Adjust the three-way stopcock to allow saline to flow into the oXiris® set arterial line an restart PrismafleX eXeed™ II to return blood into the venous reservoir.
• Register all manoeuvres, changes and adjustments in software settings and any technical problem during the procedure.
The oXiris® membrane will be only employed for adsorption (neither convection nor diffusion will be performed) during all CPB time. Using CPB flow, patient will not require venous catheter access neither changes in CPB normal settings.
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
- Single (Participant)
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.
- •Non emergent cardiac surgery requiring CPB.
- •Written informed consent from patient or legal surrogates
排除标准
- •Missing informed consent.
- •Planned CPB hypothermia <32ºC or cardiac arrest.
- •Emergency surgery.
- •Acute infective endocarditis.
- •Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).
- •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).
研究组 & 干预措施
CPB-OXIRIS®
Non emergent cardiac surgery patients with CPB requirement.
干预措施: OXIRIS® (Device)
CPB-Standard
Non emergent cardiac surgery patients with CPB requirement.
结局指标
主要结局
Safety with the use of CPB. Number of complications reported.
时间窗: 24 hours
Patients who underwent cardiac surgery with no related complications due to CPB (0 complications). Complications will be defined as those adverse effects related to technique that need an extra attention out of standard proceedings.
Cell-free serum hemoglobin
时间窗: 24 hours
Cell-free serum hemoglobin concentration will be measured in order to evaluate intravascular hemolysis. Determinations will be measured at T1 (CPB end), and T3 (24hours).
次要结局
- Creatinine and Urine output after cardiac surgery.(7 days)
- Cytokine circulatory levels during CPB and up to 24 hours after surgery.(24 hours)
研究者
JOSE LUIS PEREZ FERNANDEZ
MD
Hospital Universitari de Bellvitge