Clinical Utility and Performance of the Sepsis ImmunoScore: A Prospective Cohort Device Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,000
- 主要终点
- Sepsis diagnosis
研究概览
简要总结
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
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
- •Adult (age 18 years or older) patients presenting to hospitals and emergency departments of medical institutions across the United States.
- •Adult (age 18 years or older) patients suspected of sepsis.
排除标准
- 未提供
研究组 & 干预措施
Adult patients at risk of clinically significant events
Adult patients suspected of sepsis
干预措施: Sepsis ImmunoScore (Diagnostic Test)
结局指标
主要结局
Sepsis diagnosis
时间窗: 24 hours
meeting sepsis-3 criteria within 24 hours of Sepsis ImmunoScore order
SEP-1 bundle compliance
时间窗: through study completion, an average of 1 year
proportion of patients meeting SEP-1 bundle criteria for whom all bundle components are delivered within the required time frame
Number of clinically significant events such as infection, sepsis, critical care interventions, escalation of care, mortality
时间窗: through study completion, an average of 1 year
(e.g., vasopressor support, renal replacement therapy, non-invasive or invasive respiratory ventilation)
次要结局
- Time to antibiotic administration(through study completion, an average of 1 year)
- Coding compliance including appropriate clinical documentation to justify a diagnosis of sepsis(through study completion, an average of 1 year)
- Hospital length of stay(through study completion, an average of 1 year)
- ICU length of stay(through study completion, an average of 1 year)
- Total charges(through study completion, an average of 1 year)
- In-hospital mortality rate(through study completion, an average of 1 year)