Clinical Evaluation of Droplet Digital Polymerase Chain Reaction in Combination With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department: A Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 主要终点
- Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis
研究概览
简要总结
Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. This prospective multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR combined with transcriptome analysis methods.
详细描述
Rapid identification of pathogens and early warning of host response are key to improve the prognosis of sepsis. Establishing a comprehensive identification system based on pathogen identification and host immune status is an effective way to achieve early warning stratification of patients with infections in the emergency department. Therefore, based on our preliminary single-center study, this prospective multicenter clinical study will combine droplet digital PCR (ddPCR) and transcriptomic molecular target assay for validation in patients with suspected sepsis in the emergency department. The purpose is to (1) compare the efficacy of ddPCR with blood culture for early diagnosis and prognosis; (2) assess the diagnostic value of transcriptomic molecular targets based on 29 messenger RNA for the presence or absence of infection as well as infectious agents, and to evaluate their efficacy for prognosis; and (3) assess the diagnostic and therapeutic monitoring value of ddPCR combined with transcriptome analysis methods. In a word, this study will be undertaken to assess the diagnostic and therapeutic monitoring value of early warning models for sepsis in emergency department and to promote them to improve the identification ability of emergency infections.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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, regardless of sex
- •MSS≥2 score
- •written informed consent obtained
排除标准
- •Age < 18 years, regardless of sex
- •Patient's ICU length of stay <24 hours
- •Malignant tumor, HIV patients or any terminal-stage disease
- •Known pregnancy or lactation
- •Participation in other clinical trials
- •Inadequate clinical information or missing experimental data
- •No signed informed consent obtained
结局指标
主要结局
Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis
时间窗: 7days
Diagnostic efficiency of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine
Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis
时间窗: 28 days
Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine
次要结局
- 7-day all-cause mortality rate(7 days)
- 28-day all-cause mortality rate(28 days)
- 90-day all-cause mortality rate(90 days)
- Antimicrobial Resistance and antibiotic application(7 days)
