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临床试验/NCT01231698
NCT01231698已完成2 期

Strict Heart Rate Control With Esmolol in Septic Shock: a Randomized, Controlled, Clinical Pilot Study

Andrea Morelli1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
154
试验地点
1
主要终点
heart rate

研究概览

简要总结

The purpose of this study is investigate the effects on systemic hemodynamics and organ function of esmolol when used to maintain heart rate below a predefined threshold in patients with septic shock.

详细描述

154 septic shock patients with heart rate > of 95 bpm and requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation, will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous esmolol infusion at any doses to maintain heart rate between 95 and 80 bpm b)to a standard treatment without heart rate control(control; each n = 77). In both groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization,data from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72, and 96 hours. The protocol will require that esmolol be infused continuously at any doses to maintain the predefined heart rate threshold until one the following events occur: the patient die, a serious adverse effect attributed to the study drug infusion, or the patient has been discharged from ICU.

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

入选标准

  • septic shock criteria
  • presence of heart rate > 95 bpm.

排除标准

  • Pregnancy
  • age < 18

研究组 & 干预措施

esmolol

Experimental

干预措施: esmolol (Drug)

control

Other

干预措施: control (Other)

结局指标

主要结局

heart rate

时间窗: over a period of 96 hrs

次要结局

  • systemic hemodynamics(over a period of 96 hours)

研究者

发起方
Andrea Morelli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Andrea Morelli

MD

University of Roma La Sapienza

研究点 (1)

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