A Randomized, Controlled Trial: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change of plasma interleukin (IL)-6 level
研究概览
简要总结
Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During extracorporeal membrane oxygenation (ECMO) support, the inflammatory response is intense and complex. It may cause infection, cell damage, organ dysfunction and even death. Hemoperfusion can adsorb inflammatory factors and reduce the inflammatory reaction. CS patients who are likely to receive veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support will be enrolled and randomized with a 1:1 allocation to a simultaneous hemoperfusion arm vs. standard care arm.
- The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
- The patients in the standard care arm will not receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
The primary outcome is the change of plasma interleukin (IL)-6 level after hemoperfusion is commenced.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years.
- •Admission to ICU.
- •Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate.
- •ECMO will supply cardiopulmonary support to the patient
- •The patients will be enrolled and randomized when ECMO is commenced less than 24 hours.
排除标准
- •Refusal of consent.
- •Active hemorrhage or thrombocytopenic purpura
- •Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
结局指标
主要结局
change of plasma interleukin (IL)-6 level
时间窗: 3 days
次要结局
- Rate of Multiple organ dysfunction syndrome (MODS)(30 days)
- All-cause mortality(30 days)
- change of other inflammatory factor level(3 days)
- Duration on invasive ventilation(60 days)
- Hospital length of stay(60 days)
- Rate of infection(30 days)
- Duration on extracorporeal membrane oxygenation (ECMO) support(60 days)
- Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)(30 days)
- ICU length of stay(60 days)
- Rate of adverse event(30 days)
研究者
Xiaotong Hou
Director of Center for Cardiac Intensive Care
Beijing Anzhen Hospital