Evaluation of MDW for Early Detection of Sepsis In the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 947
- 试验地点
- 2
- 主要终点
- Identification of sepsis based on Sepsis-2 criteria
研究概览
简要总结
The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of Emergency Department (ED) adults who have blood draw including Complete Blood Count with differential (CBC-DIFF) ordered upon presentation in a Spanish & French hospital and to verify cut-off for Tri-potassium ethylenediaminetetraacetic acid (K3EDTA).
详细描述
To confirm the clinical validity and performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of ED adults who have blood draw including CBC with Differential ordered upon ED presentation. Septic patients are identified as those with values equal to or above the MDW threshold and non-septic patients are those with MDW values below the threshold. As the anticoagulant used at the sites is K3EDTA, the cut-off value will be assessed using sepsis cases and all corresponding non-sepsis to confirm optimal cut-off.
To explore the added value of this parameter in a patient diagnostic pathway that includes the use of procalcitonin (PCT) or C reactive protein (CRP) for the identification of septic patients All enrolled subjects will have PCT/ CRP assay performed per protocol Plasma will be aliquot and stored frozen for subsequent testing at Beckman Coulter for other sepsis biomarker tests (additional PCT& CRP tests and interleukin-6 (IL-6) on the sponsor's devices
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
- •CBC-DIFF upon presentation
- •Adults (18-89) of all races & ethnicities
- •Signed Informed Consent
排除标准
- •Previously enrolled
- •Incomplete Informed Consent
- •Subject discharged <4 hours from presentation
- •PCT or CRP not performed per protocol
- •Pregnancy
- •Prisoners
- •Subjects Under Custody or Guardianship
结局指标
主要结局
Identification of sepsis based on Sepsis-2 criteria
时间窗: Within 4 hours of presentation
Determination of diagnostic accuracy based on Receiver Operating Characteristic Curves
次要结局
- Identification of sepsis based on Sepsis-3 criteria(Within 4 hours of presentation)