Droplet Digital PCR Combines With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department

Tongji University

Status: Not yet enrolling

Conditions: Emergent Infections, Treatment; Sepsis

Treatments: Diagnostic Test: Droplet digital PCR

Study type: Observational

Funder types: Other

Identifiers

NCT06028178

emergency medicine 20230824

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 years, regardless of sex
• MSS≥2 score
• written informed consent obtained

Exclusion criteria

• 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

Trial design

360 participants in 2 patient groups

Experimental group

Description:

The experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis.

Treatment:

Diagnostic Test: Droplet digital PCR

Control group

Description:

The control group will recruit 60 participants undergoing blood culture only.