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

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06028178
• Other study ID #: emergency medicine 20230824
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: September 2023
• Source: Shanghai East Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic efficiency of ddPCR combined with transcriptomic analysis in suspected sepsis	Diagnostic efficiency of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine	7days
Primary	Prognostic value of ddPCR combined with transcriptomic analysis in suspected sepsis	Prognostic value of ddPCR combined with transcriptomic analysis for suspected sepsis in the emergency medicine	28 days
Secondary	7-day all-cause mortality rate	Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.	7 days
Secondary	28-day all-cause mortality rate	Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.	28 days
Secondary	90-day all-cause mortality rate	Evaluation of combined examination by ddPCR and transcriptomic analysis for the evaluation of the prognosis of the sepsis.	90 days
Secondary	Antimicrobial Resistance and antibiotic application	Evaluation of combined examination by ddPCR and transcriptomic analysis for the the value of guiding clinical drug therapy.	7 days