Sepsis Early Evaluation Through Rapid Ultrasound and Venous Gas Analysis: a Prospective Observational Study in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of participants who are dead for any cause
研究概览
简要总结
Sepsis is a life-threatening condition, caused by a systemic infection. It is particularly dangerous in already fragile populations and needs to be identified quickly to be treated as fast as possible, as discussed during the 2016 sepsis consensus and highlighted by the 2021 Surviving Sepsis Campaign. Yet, while there are scores to quickly identify patients who are at an increased risk of mortality (namely quick-SOFA, q-SOFA), these scores are also highly unspecific and cannot guarantee an adequate risk stratification. Therefore, it would be extremely valuable to further stratify mortality risk in patients who present to the emergency medical evaluation, especially those who present with stable hemodynamics but are at increased risk of decompensation during hospital stay. Furthermore, in the emergency room, it is sometimes impossible to re-evaluate patients regularly, thus, it would be important to immediately identify high-risk patients. Unfortunately, at the moment, there is no consensus. Through this study, the investigators will try to identify ultrasound parameters and biochemical markers which can be obtained during the first visit in the emergency room (ER) and that allow a quick risk stratification of patients with sepsis.
The rationale of this study is to improve early identification of septic patients who are at risk of rapid deterioration in the course of their permanence in the ER and the hospital wards in general. The investigators selected a number of clinical, laboratory and bedside ultrasound parameters which have been previously shown to be correlated with mortality in sepsis, and will seek to identify which among these parameters best correlates with prognosis when acquired in the very first minutes of a patient's arrival in the ER. The objective would be to analyse these parameters and eventually to propose a new early sepsis score which might help the emergency physician to better tailor its efforts and clinical resources to the most sick patients.
详细描述
The investigators propose a multicenter, prospective, observational study which will take place between January 2023 until the pre-specified target number of 400 patients is reached, in any case within 1 year, in three major urban, teaching Hospitals. At the end of the enrolling phase, data analysis and conclusion of the study will occur within 6 months.
These patients will undergo a regular emergency room (ER) visit, during which a venous blood gas and a bedside ultrasound will be obtained, along with the collection of anamnestic and clinical parameters. All of these procedures normally take place in the first medical evaluation in the ER, therefore no unnecessary procedures or harm to patients will take place.
The data which will be obtained during the first medical visit include:
Anamnestic and demographic data:
- Age;
- Sex;
- History of hypertension, diabetes, congestive heart failure, chronic lung disease, chronic kidney failure, severe immunosuppression, cancer;
- Infective source, if known or suspected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult, non pregnant patients admitted to the ED with a clinical suspicion of sepsis or septic shock
排除标准
- •Age less than 18 years old
- •Pregnancy
结局指标
主要结局
Number of participants who are dead for any cause
时间窗: 7 days
categorical variable
次要结局
- Number of participants who die during the emergency department visit(48 hours)
- Number of participants who are dead for any cause(30 days)
- Number of patients who require ICU admission(30 days)
- Length of hospitalisation(6 months)
研究者
FRANCESCHI FRANCESCO
Professor Francesco Franceschi, Head of the Emergency Medicine Department
Fondazione Policlinico Universitario Agostino Gemelli IRCCS