Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Cardiac Output
研究概览
简要总结
Pyruvate is an intermediate of energy metabolism and was shown to possess pronounced positive inotropic effects in vitro and in vivo without altering myocardial oxygen consumption. Moreover, it was shown that the effects of beta-adrenergic stimulation were potentiated. Thus, it might be possible to save catecholamines in patients with severe heart failure or cardiogenic shock. This study was designed to test the hemodynamic effects of pyruvate administered into a coronary artery in addition to intra-aortic balloon pump counterpulsation in patients with severe heart failure or in patients with acute myocardial infarction and cardiogenic shock after having performed percutaneous coronary intervention. A pronounced improvement in hemodynamics is expected to occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients male/female
- •Age: 18 - 85 years
- •Weight: 45 - 110 kg
- •Height 150 - 195 cm
- •Clinically signs of heart failure (NYHA III-IV) refractary to therapy or cardiogenic shock in acute myocardial infarction
- •written informed consent or witnessed verbal consent or presumed will (compassionate use)
排除标准
- •Malignoma
- •Clinically significant cardiac valve stenosis
- •Participation in another clinical trial with relevant or probable drug-interactions
- •Pregnancy or lactation
- •Addiction
- •Poor compliance
研究组 & 干预措施
A
Pyruvate
干预措施: Pyruvate (Drug)
结局指标
主要结局
Cardiac Output
时间窗: 60 minutes
次要结局
- Cardiac Index(60 minutes)
- Arterial Pressure(60 minutes)
- Pulmonary capillary wedge pressure(60 minutes)
- Pulmonary artery pressure(60 minutes)
- systemic vascular resistance(60 minutes)
- pulmonary vascular resistance(60 minutes)
- heart rate(60 minutes)
- stroke volume(60 minutes)
- catecholamine need(60 minutes)
- safety(60 minutes)