Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Echocardiographic assessment of heart function
研究概览
简要总结
After initial hemodynamic stabilization, 36 septic shock patients with heart rate > of 90 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg will be randomised into two groups, esmolol group and control group. Patients allocated to esmolol group will receive a continuous esmolol infusion to maintain a lowering of heart rate of 10%. Norepinephrine will be titrated to achieve a MAP more than 65 mmHg. To investigate myocardial performance, the investigators will assess Tissue Doppler imaging by echocardiography and hemodynamic measures. Data will be obtained at baseline ,after esmolol infusion once achieved the predefined heart rate threshold and 72hours after esmolol infusion.
详细描述
primary outcome were determined according to our previous study of tissue doppler.
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
- None
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
- •septic shock
- •fluid optimization
- •with a cardiac index > 3 l/min/m2
- •Heart Rate >90 /min
排除标准
- •Cardiogenic shock
- •Bradycardia
- •History of Severe Asthma
- •Indications against Esmolol
研究组 & 干预措施
Esmolol
After, at least six hours of hemodynamic optimization, patients with a hyperdynamic shock received a conventional management with a continuous infusion of Esmolol titrated to gain a 10% reduction in heart rate. This infusion is maintained for 72 hours.
干预措施: Esmolol (Drug)
结局指标
主要结局
Echocardiographic assessment of heart function
时间窗: over a period of 72 hrs
peak systolic velocity measured at the mitral annulus decreased 30% compared with control group
次要结局
- Effects on vasopressor requirement(over a period of 72 hrs)
- 90-day hospital mortality(90 days)