Clinical trial NCT06028178: Droplet Digital PCR Combines With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Emergent Infections, Treatment
Keywords: Droplet digital PCR
Transcriptomic molecular target assay
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective inclusion of patients with suspected sepsis with MSS ≥ 2 in the emergency department of Shanghai East Hospital, Shanghai Pudong New District Zhoupu Hospital, Shanghai Pudong New District Gongli Hospital, Shanghai Pudong Hospital and Shanghai Punan Hospital Hospital, Shanghai Pudong Hospital, Shanghai Pudong New Area Hospital and Shanghai Pudong New Area Punan Hospital. The patients will be randomized by stratified grouping and assigned to two parallel groups in the ratio of 5:1.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis
timeFrame: 7days
measure: Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis
timeFrame: 28 days
Secondary outcomes:
measure: 7-day all-cause mortality rate
timeFrame: 7 days
measure: 28-day all-cause mortality rate
timeFrame: 28 days
measure: 90-day all-cause mortality rate
timeFrame: 90 days
measure: Antimicrobial Resistance and antibiotic application
timeFrame: 7 days
Other outcomes:
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