Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
研究概览
简要总结
This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Age > 18 years
- •Suspected sepsis at the time of admission to the ICU
- •Direct admission from the ED to the ICU with suspected/proven sepsis.
- •Post-operative ICU admission after sepsis source control procedure
- •Inpatients admitted to the ICU from the ward with suspected sepsis onset.
- •Able to provide subject/proxy informed consent within 96h
- •Age > 18 years
- •No suspicion of sepsis at the time of admission to the ICU but at high risk for subsequent sepsis onset
- •Non-trauma admission from the ED to the ICU
- •Post-operative ICU admission
- •Severe trauma admission from the ED (injury severity score >15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma)
- •Inpatients admitted to the ICU from the ward for decompensation not initially suspected to be secondary to sepsis.
- •Able to provide subject/proxy informed consent within 96h
排除标准
- •Pre- or post-transplant patients
- •Patients admitted solely for airway monitoring, or vascular/flap check monitoring
- •Previous diagnosis of sepsis on index hospitalization.
- •Unable to provide informed consent within 96h
- •Previously enrolled in the present study.
结局指标
主要结局
Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
时间窗: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Percentage of correctly identified patients with bacterial and/or viral infections using HostDx Sepsis compared to clinical adjudications using routine clinical, laboratory, and other findings
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
时间窗: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (90-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
次要结局
未报告次要终点