Clinical Trial to Evaluate Early Sepsis Indicator Monocyte Distribution Width (MDW) for Early Detection of Sepsis or Developing Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,200
- 试验地点
- 3
- 主要终点
- sensitivity, specificity
研究概览
简要总结
This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China.
详细描述
To verify the clinical performance of MDW parameter in detection of sepsis through a multicenter, prospective study of adults undergoing complete blood count with differential ("CBC with differential") in the ED.
To clarify the cutoff 20.0 established in the pivotal trial. The cutoff was established for the objective of achieving the highest sensitivity at the optimal specificity level. Patients whose MDW value is higher than the cutoff will be identified as sepsis patients and those whose MDW value is equal to or lower than the cutoff are non-sepsis patients.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (18-89 years) presenting to ED.
- •CBC with Differential performed upon presentation as part of standard of care.
- •Subject scheduled for at least 12 hours follow-up during ED (or inpatient, if admitted to the hospital) visit
- •Signed the informed consent form
排除标准
- •Subjects previously enrolled in this study (i.e., re-enrollment to this study is not allowed).
- •The subject is discharged from the hospital within 12 hours after ED visit
结局指标
主要结局
sensitivity, specificity
时间窗: 2022.3-2024.3
sensitivity (percentage of patients with sepsis correctly identified), specificity (percentage of non-sepsis patients correctly identified) according to Sepsis-2
次要结局
未报告次要终点