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临床试验/NCT04537767
NCT04537767Unknown不适用

The Effect of Esmolol on Patients With Sepsis

Shanghai Zhongshan Hospital0 个研究点目标入组 120 人开始时间: 2020年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
REE

研究概览

简要总结

The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

详细描述

Severe sepsis, septic shock, and their complications have become the major healthcare problem that affects millions of people each year, resulting in high mortality rates. Septic responses have an extremely complex chain of events including inflammatory and anti-inflammatory processes, humoral and cellular reactions, and cardiocirculatory abnormalities. Esmolol may have some potential in treating septic shock and sepsis. The investigators conduct an RCT to explore the efficacy of esmolol in patients with septic shock and sepsis.

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 (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sepsis patients
  • HR>100bpm 6h after admission
  • with CVC and ScvO2>65%

排除标准

  • age <18 years,
  • used β-blocker before,
  • cardiac dysrhythmias,
  • need for an inotropic agent,
  • valvular heart disease,
  • hemoglobin>6g/L
  • pregnancy.

研究组 & 干预措施

ES group

Experimental

Patients randomly assigned to the ES group were treated with esmolol to control the heart rate to the target range.

干预措施: Esmolol (Drug)

control group

Placebo Comparator

Patients randomly assigned to the control group were treated with placebo.

干预措施: Placebo (Drug)

结局指标

主要结局

REE

时间窗: Day 7 after enrollment

Resting energy expenditure

次要结局

  • HR control rate(24 hours after enrollment)
  • O2ER(Day 1/3/7 after enrollment)
  • 28-day mortality rate(Day 28 after enrollment)
  • Vasoactive drug administration dose(Day 1/3/7 after enrollment)
  • Concentration of Lac(Day 1/3/7 after enrollment)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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