Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Nucleic acid load of pathogenic bacteria at different time points
研究概览
简要总结
The purpose of this study is to investigate the efficacy of droplet digital PCR (ddPCR) in identifying pathogenic organisms in ICU sepsis patients, aiming to find a method that allows early identification of pathogenic organisms and dynamic surveillance in order to assess the association between pathogenic species and loads and clinical characteristics and outcomes.
详细描述
This is a monocentric observational study. Patients admitted to the ICU with a first diagnosis of sepsis will be dynamically monitored for nucleic acid loads of pathogenic bacteria in the blood using ddPCR at different time points until the last blood sample is taken on day 28-30 or the patient is discharged from the 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
- •Patients with first diagnosis of sepsis after ICU admission
排除标准
- •Age under 18 years
- •Do not meet Sepsis 3.0 diagnostic criteria
- •Refusal to sign informed consent
结局指标
主要结局
Nucleic acid load of pathogenic bacteria at different time points
时间窗: ''Nucleic acid load of pathogenic bacteria in the blood versus time'' could have a time frame of ''0, 2-3, 4-5, 6-7, 8-9, 10-12, 13-15, 20-22, 28-30 days post admission to the ICU with the first diagnosis of sepsis''.
次要结局
- 28-day mortality(Survival status at 28 days after the first diagnosis of sepsis on admission to the ICU)