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

Not yet recruiting

• Conditions: Sepsis; Emergent Infections, Treatment
• Interventions: Diagnostic Test: Droplet digital PCR

• Registration Number: NCT06028178
• Lead Sponsor: Shanghai East Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-17
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-08
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Study Start: 2024-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Droplet digital PCR	The experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis.

Primary Outcome Measures

Name	Time	Method
Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis	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	28 days	Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine

Secondary Outcome Measures

Name	Time	Method
7-day all-cause mortality rate	7 days	Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
28-day all-cause mortality rate	28 days	Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
90-day all-cause mortality rate	90 days	Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.
Antimicrobial Resistance and antibiotic application	7 days	Evaluation of combined examination by ddPCR and transcriptomic analysis for the the value of guiding clinical drug therapy.