Sepsis Onset Warning System [SOWS] Master Enrollment Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40,000
- 试验地点
- 10
- 主要终点
- Severe Sepsis
研究概览
简要总结
This protocol will collect real-world data retrospectively from the electronic health record (EHR) as data obtained from the delivery of routine medical care to develop a machine learning (ML)-based Clinical Decision Support (CDS) system for severe sepsis prediction and detection.
详细描述
The purpose of this study is to gather data for the clinical development of the Sepsis Onset Warning System (SOWS) Software as Medical Device (SaMD) product to support a De Novo FDA submission and commercialization in the United States. Product development of SOWS is funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.
Data will be obtained from passive prospective collection of patient encounter data throughout the duration of the planned study to support the product development life cycle activities associated with developing the Sepsis Onset Warning System (SOWS) for severe sepsis risk detection. Inputs from patient health records in combination with proprietary hematology parameters developed by Beckman Coulter, such as Monocyte Distribution Width (MDW), will be used. The SOWS tool will look to use clinical measurements which are commonly and reliably available in the EHR as structured data elements, such as heart rate, temperature, blood pressure, and laboratory results and account for changes in these values over time.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All races, ages and ethnicities
- •All patients admitted to the hospital or presenting to the Emergency Department
排除标准
- •Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).
结局指标
主要结局
Severe Sepsis
时间窗: Within 6 hours from presentation to the emergency department
Identify patients having Severe Sepsis with the use of electronic health data
次要结局
- Mortality(Within 6hours from presentation to the emergency department)
- Length of Stay(Within 6hours from presentation to the emergency department)
- Re-admission Rates(Within 6hours from presentation to the emergency department)