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