ExtraCorporeal Membrane Oxygenation in the Therapy of Cardiogenic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 4
- 主要终点
- Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
研究概览
简要总结
Eligible patients with severe cardiogenic shock will be randomized to one of the two arms: immediate ECMO therapy or early conservative therapy. In the invasive group, veno-arterial ECMO will be implanted according to the local practice with flow settings to ensure sufficient tissue perfusion. With the exception of ECMO implantation in the invasive group, all other diagnostic and therapeutic procedures will be done according to the current standard of care at the tertiary cardiovascular center, including other cardiovascular interventions (i.e. percutaneous coronary intervention or cardiac surgery). Implantation of other mechanical support devices including ECMO in the primary conservative group is allowed in the case of shock progression with rise of serum lactate by 3 mmol/L in comparison with the lowest value during the past 24 hours. Follow-up include visits at 30 days, 6 moths and 12 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must fulfil criteria for rapidly deteriorating (A) or severe (B) cardiogenic shock:
- •A. Rapidly deteriorating cardiogenic shock is defined as progressive hemodynamic instability necessitating repeated bolus administration of vasopressors to maintain mean arterial pressure > 50 mmHg + impaired left ventricle systolic function (Left ventricle ejection fraction (LVEF) < 35% or LVEF 35-55% in case of severe mitral regurgitation or aortic stenosis) or
- •B. In severe cardiogenic shock all following criteria should be met:
- •Hemodynamic:
- •Cardiac Index (CI) < 2.2 L/min/m2 + norepinephrine dose > 0.1 μg/kg/min + dobutamin dose > 5 μg/kg/min or Systolic blood pressure < 100 mmHg + norepinephrine dose > 0.2 μg/kg/min + dobutamin dose > 5 μg/kg/min + (LVEF < 35% or LVEF 35-55% + severe mitral regurgitation or aortic stenosis)
- •Lactate - two consecutive values ≥ 3 mmol/L (with at least 30 min between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors or SvO2 - two consecutive values < 50% (with at least 30 min between measurements), with non-increasing trend on steady doses of inotropes and/or vasopressors
- •Hypovolemia must be excluded:
- •Central venous pressure > 7 mmHg or pulmonary capillary wedge pressure > 12 mmHg
排除标准
- •Age < 18 years
- •Life expectancy lower than 1 year
- •High suspicion of pulmonary emboli or cardiac tamponade as a cause of shock
- •Significant bradycardia or tachycardia which might be responsible for hemodynamic instability and not treated by pacing or cardioversion
- •Cardiac arrest survivors remaining comatose
- •Hypertrophic obstructive cardiomyopathy
- •Peripheral artery disease disabling insertion of outflow cannula to femoral artery
- •Moderate to severe aortic regurgitation
- •Aortic dissection
- •Uncontrolled bleeding or TIMI major bleeding within last 6 months
- •Known encephalopathy
研究组 & 干预措施
Invasive
Immediate veno-arterial extracorporeal membrane oxygenation (ECMO)
干预措施: Veno-arterial extracorporeal membrane oxygenation (ECMO) (Device)
Conservative
Early conservative therapy according to standard practice
干预措施: Early conservative therapy according to standard practice (Other)
结局指标
主要结局
Composite of death from any cause, resuscitated circulatory arrest, and implantation of another mechanical circulatory support device
时间窗: 30 days
次要结局
- All-cause mortality(12 months)
- Neurological outcome (according to Cerebral Performance Category scale)(30 days)
- All-cause mortality(30 days)
- All-cause mortality(6 months)
研究者
Petr Ostadal
Dr.
Na Homolce Hospital