Post Market Observational Study of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) and Potential Reduction in Time to Antibiotics - Washington University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,139
- 试验地点
- 1
- 主要终点
- Potential reduction of Time to Antibiotics
研究概览
简要总结
The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).
详细描述
The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 race and ethnicities
- •Presenting to the emergency department with suspicion of infection
- •Whose assessment includes a CBC with differential
- •Meets EMR Sepsis Definition
排除标准
- •Pregnancy
- •Prisoners
- •Transfers from other ED
- •Previously enrolled
结局指标
主要结局
Potential reduction of Time to Antibiotics
时间窗: 12 hours after ED presentation
Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated
次要结局
- Performance(12 hours after ED presentation)