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临床试验/NCT04497155
NCT04497155已完成不适用

The Association of Norepinephrine Use in Pre-hospital Transport and Early Mortality in Hemorrhagic Shock

University of Maryland, Baltimore0 个研究点目标入组 2,164 人开始时间: 2013年1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
状态
已完成
入组人数
2,164
主要终点
Early mortality

研究概览

简要总结

The effect of early, prehospital norepinephrine use in patients with traumatic shock on mortality is unknown. Recent existing observational evidence from single system data (US, France, Japan) are conflicting. The investigators hypothesize that prehospital norepinephrine is associated with decreased mortality when used in patients with traumatic shock.

详细描述

Prehospital hypotension is associated with worse clinical outcomes in patients who sustain traumatic injuries. Administration of vasoactive medications, including norepinephrine, is not advocated in North American trauma systems due to the belief that vasopressors will worsen clinical outcomes and increase mortality. However, in European trauma systems prehospital vasopressor administration is included as part of the guidelines for the management of hypotension and hemorrhagic shock. There are multiple physiologic explanations for why prehospital vasopressor administration may be useful in patients with traumatic shock, such as providing adequate blood pressure to maintain vital signs until arrival at the trauma center, allowing adequate organ perfusion in the setting of low blood flow, and supplementing decreased hormone production in the later stages of hemorrhagic shock.

The purpose of this retrospective study is to investigate if prehospital norepinephrine administration is associated with decreased mortality in patients with traumatic shock. The investigators will collect patient data from previously collected sources of information and trauma databases from three separate locations: the TRAUMABase consortium in Paris, France; TRENAU trauma database from Grenoble, France; and the R Adams Cowley Shock Trauma Center in Baltimore, MD, USA. The investigators will perform statistical modeling to propensity score match patients that received prehospital vasopressors with patients that did not receive prehospital vasopressors and assess the association with 24-hour and 28-day mortality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-90 years
  • Blunt traumatic mechanism of injury
  • Admitted to the trauma center from the scene of injury
  • Systolic blood pressure during prehospital transport or at admission to the trauma center <100 mmHg

排除标准

  • Penetrating mechanism of injury
  • No vital signs at the scene of injury
  • Prehospital cardiac arrest
  • Transferred to the trauma center from another hospital

研究组 & 干预措施

Prehospital norepinephrine

Trauma patients that received norepinephrine in the prehospital setting or in the resuscitation unit .

干预措施: Norepinephrine (Drug)

结局指标

主要结局

Early mortality

时间窗: Admission to the trauma center to 24-hours after admission

Death within 24-hours of admission to the trauma center

次要结局

  • 28-day mortality(Admission to the trauma center to 28-days after admission)

研究者

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

Justin Richards

Associate Professor of Anesthesiology

University of Maryland, Baltimore

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