Anti-inflammatory and Cardiac Effects of Esmolol in Septic Shock. ESMOSEPSIS Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2)
研究概览
简要总结
Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the inflammatory response. Experimental works demonstrated that Esmolol, an highly selective beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono centric, double blind, randomized clinical work in septic shock patients has shown that Esmolol administration is safe and reduces effectively heart rate. However there are only sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human resuscitated septic shock patients treated by esmolol.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •septic shock patients following the definition of the Surviving Sepsis Campaign
- •femoral and central venous catheters for thermodilution monitoring
- •fluid optimization
- •with a cardiac index > 3 l/min/m2
- •Heart Rate >100 /min
排除标准
- •Cardiogenic shock
- •Bradycardia
- •History of Severe Asthma
- •Indications against esmolol
研究组 & 干预措施
ESMOLOL
Resuscitated, hyperkinetic septic shock patients are treated with esmolol in order to reduce heart rate of 20% during 6 hours. During the intervention period, multimodal macro and micro hemodynamic data are recorded.
干预措施: Esmolol (Drug)
结局指标
主要结局
Hemodynamic effects of Esmolol in septic shock patients (Value of cardiac index l/min/m2)
时间窗: Before administration (H0) and each hour (H1-H2-H3-H4-H5-H6) during the whole administration period and one hour after Esmolol cessation (H7)
Compare, in septic shock patients, the mean cardiac index before and after administration of Esmolol.
次要结局
- Effects on vasopressor requirement (amount of norepinephrine infused in microgram/kg) during Esmolol administration(Record of each change in vasopressor dosage to maintain a mean arterial pressure at 70 mmHg during the whole Esmolol administration period (H0 to H6) and one hour after esmolol cessation (H7))
- Microcirculatory and regional circulation effects of Esmolol in septic shock patient(Before (H0), 6 hours after Esmolol introduction (H6) and 1 hour after esmolol cessation (H7))
- Changes in the Cytokine pattern(pro and anti inflammatory cytokines assay) induced by Esmolol administration in septic shock patients(Before administration of Esmolol (H0) and 6 hours after introduction of Esmolol (H6))
- Description of the cardiac function during Esmolol Administration in septic shock patients(Before administration (H0), at 4 hours, 6 hours after introduction and 1 hours after esmolol cessation)