NCT04451798已完成不适用
JENA Mechanical Assist Circulatory Support Trial-JENAMACS-hemodynamic
University of Leipzig3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
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
- 3
- 主要终点
- Hemodynamic Parameters due to PA catheterisation
研究概览
简要总结
Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 91 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiogenic shock following acute MI or acute heart failure with
- •systolic BP < 90 mm Hg over > 30 min or inotropes for support of cardiac output and BP with
- •signs of left heart failure and pulmonary congestion
- •and end-organ hypo perfusion with somnolence or cold, pale skin, or oliguria or serum lactate >2 mmol/l
排除标准
- 未提供
研究组 & 干预措施
Intervention
Experimental
Impella implantation and hemodynamic measurement
干预措施: Impella CP microaxial pump (Device)
结局指标
主要结局
Hemodynamic Parameters due to PA catheterisation
时间窗: Day 1
Pulmonary capillary Wedge pressure in dependence of Impella pump level
Echocardiographic Parameters of left and right heart function
时间窗: Day 1
LV- size in dependence of Impella pump level
次要结局
未报告次要终点
研究者
Sven Möbius-Winkler
Principal Investigator, Clinical Professor
University of Leipzig
研究点 (3)
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