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临床试验/NCT02794025
NCT02794025已完成不适用

The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients With Severe Sepsis: a Prospective Cohort Study .

Fujian Provincial Hospital0 个研究点目标入组 151 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
151
主要终点
The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.

研究概览

简要总结

The purpose of this study was to investigate the effect of esmolol on hemodynamic parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis

详细描述

enrollment:151 patients

Inclusion criteria: (1) age > 18 years; (2) severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock, who (3) mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg; and (4) satisfactory sedation and analgesic treatment, with HR > 100 bpm.

研究设计

研究类型
Interventional
分配方式
Non 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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years;
  • severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock,
  • mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg;
  • satisfactory sedation and analgesic treatment, with HR > 100 bpm.

排除标准

  • pre-existing cardiac dysfunction, valvular heart disease, high-degree atrioventricular block;
  • acute or chronic pulmonary heart disease;
  • a history of serious asthma;
  • chronic renal insufficiency;
  • cancer, autoimmune diseases, or contraindications for placement of deep venous catheter;
  • insulin-dependent diabetes.

研究组 & 干预措施

esmolol group

Experimental

patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava.

干预措施: Esmolol (Drug)

control group

Sham Comparator

Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.

干预措施: natural saline (Drug)

结局指标

主要结局

The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.

时间窗: 28 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiuling Shang

the ethic committee of Fujian Provincial Hospital

Fujian Provincial Hospital

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