跳至主要内容
临床试验/NCT06028178
NCT06028178尚未招募不适用

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

Shanghai East Hospital0 个研究点目标入组 360 人开始时间: 2024年5月1日最近更新:
适应症

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

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)

研究者

发起方
Shanghai East Hospital
申办方类型
Other
责任方
Sponsor

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