Droplet Digital PCR Combines With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental group The experimental group will recruit 300 participants undergoing blood culture, droplet digital PCR and transcriptome analysis. |
Diagnostic Test: 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.
Other Names:
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| Control group The control group will recruit 60 participants undergoing blood culture only. |
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age ≥ 18 years, regardless of sex
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MSS≥2 score
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written informed consent obtained
Exclusion Criteria:
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Age < 18 years, regardless of sex
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Patient's ICU length of stay <24 hours
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Malignant tumor, HIV patients or any terminal-stage disease
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Known pregnancy or lactation
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Participation in other clinical trials
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Inadequate clinical information or missing experimental data
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No signed informed consent obtained
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai East Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- emergency medicine 20230824