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临床试验/NCT04134624
NCT04134624终止不适用

EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock

HealthPartners Institute2 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2019年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
215
试验地点
2
主要终点
In hospital mortality

研究概览

简要总结

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a stepwise study that aims to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS.

详细描述

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a pilot project. This is a stepwise study that will build on previously published literature to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS. The primary aim is to take processes that have been developed for use in this patient population during Emergency Department care and to advance these same processes "downrange" to initiate them prior to hospital arrival. Early antibiotic administration has been shown to decrease mortality in a time dependent fashion when implemented in hospitalized patients. The investigators hypothesize that initiating antibiotics prior to hospital arrival will improve morbidity and mortality while also addressing quality metrics that are publicly reported for this patient population.

This pilot study will be conducted in two consecutive phases, responding to the following aims.

Aim 1: Evaluate the feasibility that paramedics can obtain blood cultures from general patients prior to hospital arrival with a contamination rate that is statistically equivalent to that for blood cultures obtained in Emergency Department.

Aim 2 (primary aim): Investigate whether prehospital paramedic initiated broad spectrum antibiotics, administered after blood cultures are obtained, will result in improved mortality rates for patients, when compared to historical controls.

研究设计

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

入选标准

  • Phase 1 (blood culture contamination rate quantification phase)
  • Hemodynamically stable patients ≥18 years old being transported by Lakeview EMS to Lakeview Hospital who will have an intravenous access established as part of their routine prehospital care are eligible for this study.
  • English speaker
  • Phase 2 (blood cultures + antibiotics prehospital)
  • a. Patients with fever >38oC + ≥2 qSOFA who are being transported to Lakeview Hospital that originate as a 911 call

排除标准

  • Patients age <18 years
  • Hemodynamic instability
  • Documented allergy to Penicillin or inability to determine patient's medication allergies
  • Pregnant patients
  • Patients being transferred from one hospital to another
  • Non-English speakers

结局指标

主要结局

In hospital mortality

时间窗: Through duration of hospitalization, average 1 week

Mortality during hospital admission following enrollment

ICU length of stay

时间窗: Through duration of ICU stay, average 3 days

Length of stay in ICU during hospital admission following enrollment

Hospital length of stay

时间窗: Through duration of hospitalization, average 1 week

Length of stay of hospitalization following enrollment

30 day mortality

时间窗: 30 days

Mortality 30 days following enrollment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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