RecruitingNCT07599644

Sepsis Multiomic Analysis & Risk sTratification in China

Sepsis Multiomic Analysis & Risk sTratification in China (China SMART-1): A Prospective Observational Cohort Study


Sponsor

Yuebei People's Hospital

Enrollment

1,400 participants

Start Date

Jun 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

Objectives: 1. Perform Bulk RNA-seq transcriptome sequencing on enrolled samples to screen sepsis-specific mRNA diagnostic biomarkers and evaluate their diagnostic efficacy for early sepsis in the ICU; establish a molecular risk stratification system for sepsis based on mRNA expression profiles, and clarify the immunobiological characteristics, clinical manifestation differences, and prognostic risk levels of each stratification. 2. Integrate core indicators screened from transcriptome sequencing, open-source databases, and previous studies to establish and optimize an RT-LAMP rapid detection method for core sepsis targets, validate its diagnostic accuracy, specificity, and reproducibility, and construct a rapid sepsis diagnostic model adapted to bedside scenarios. 3. Integrate core indicators screened from open-source databases and previous studies to screen sepsis-specific diagnostic biomarkers in plasma and urine via PRM and metabolomics, complete protein/metabolic level validation using immunological methods (ELISA), construct a combined diagnostic model for sepsis, and complete internal validation and efficacy evaluation.


Eligibility

Min Age: 18 Years

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Locations(1)

Yuebei People's Hospital

Shaoguan, Guangdong, China

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NCT07599644


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