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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis Emergent Infections, Treatment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

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

Droplet digital PCR

Intervention Type DIAGNOSTIC_TEST

Droplet digital PCR has potential in resolving polymicrobial infection because it simultaneously achieves unprecedented high sensitivity , high specificity, and absolute quantification without the need for a standard curve.

Control group

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

No interventions assigned to this group

Interventions

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Droplet digital PCR

Droplet digital PCR has potential in resolving polymicrobial infection because it simultaneously achieves unprecedented high sensitivity , high specificity, and absolute quantification without the need for a standard curve.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Transcriptomic analysis

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No