Increased Adsorption Membranes During Cardiopulmonary Bypass. a Randomized Controlled Trial to Evaluate Impact of OXiris® Membrane in Cardiac Surgery Associated Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 6
- 主要终点
- Non presence of CSA-AKI within the first 7 days after cardiac surgery.
研究概览
简要总结
Our project intends to reduce cardiac surgery associated - acute kidney injury (CSA-AKI) in non emergent patients with the use of an increased adsorption membrane (oXiris®) connected to the cardiopulmonary bypass (CPB) circuit, besides evaluating the inflammatory response by quantifying inflammatory mediators during and after cardiac surgery with CPB. Our study is a randomized and controlled multicentre trial that includes recruiting centres with a long experience in cardiac surgery with CPB.
The primary endpoint of the project is to evaluate the ability of oXiris® to reduce the incidence of CSA-AKI in patients undergoing non emergent cardiac surgery with an expected CPB time of more than 90 minutes (doble valve replacement or valve replacement plus coronary artery bypass graft). With the goal of reducing by 10% (from 25 to 15%) the risk of CSA-AKI during the first postoperative week a sample size of 340 patients has been calculated.
Secondary endpoints are two; first, to evaluate the effect of using oXiris® on survival, clinical course and removal capacity of cytokines and lipopolysaccharide (LPS) during and after CPB; and second, to assess the predictive value for CSA-AKI of some new biomarkers, such as uNAD (urinary nicotinamide adenine dinucleotide).
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.
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 patients requiring 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
- •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 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
Non presence of CSA-AKI within the first 7 days after cardiac surgery.
时间窗: 7 days
Participants who underwent cardiac surgery with no CSA-AKI within the first 7 days after cardiac surgery. CSA-AKI will be defined as at least AKI stage≥1 (according to AKI KDIGO classification) during the first 7 days of cardiac surgery. Patients with previous mild chronic kidney disease (CKD) will also be classified as CSA-AKI according to changes of creatinine respect to baseline creatinine or urine output decrease within the first 7 days after cardiac surgery.
次要结局
- 90 day survival after cardiac surgery.(90 days)
- Urinary and blood levels of NAD values after cardiac surgery.(First 24 hours after cardiac surgery.)
- ICU length of stay after cardiac surgery.(Participants will be followed for the duration of ICU stay, an expected average of 2 days.)
- Cytokine circulatory levels during CPB and up to 24 hours after surgery.(First 24 hours after cardiac surgery.)
- Hospital length of stay after cardiac surgery.(Participants will be followed for the duration of hospital stay, an expected average of 1 week.)
- LPS circulatory levels during CPB and up to 24 hours after surgery.(First 24 hours after cardiac surgery.)
- Composite Creatinine and Urine output after cardiac surgery.(7 days after cardiac surgery.)
研究者
JOSE LUIS PEREZ FERNANDEZ
MD
Hospital Universitari de Bellvitge