Sepsis Multiomic Analysis & Risk sTratification in China (China SMART-1): A Prospective Observational Cohort Study
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, and delayed diagnosis remains a major driver of mortality, while traditional biomarkers (PCT, CRP, lactate) have limited early sensitivity and timeliness. This prospective, single-center, observational cohort study at Yuebei People's Hospital will enroll approximately 1400 ICU patients (1000 with sepsis and 400 non-sepsis controls) to build a comprehensive multi-omics biobank and identify early diagnostic and risk-stratification biomarkers for sepsis. Using bulk RNA sequencing, targeted proteomics (PRM), targeted metabolomics, and ELISA validation, the study aims to: (1) screen mRNA diagnostic biomarkers and establish a molecular risk-stratification system; (2) develop and validate an RT-LAMP rapid bedside detection method; and (3) identify and validate plasma and urine protein/metabolite biomarkers and build a combined diagnostic model. The specific candidate biomarker identities are maintained confidentially and will be disclosed with the primary results.
• Age ≥ 18 years
• Meets the Sepsis-3 diagnostic criteria: confirmed or suspected infection with an increase in SOFA score of ≥ 2 points from baseline
• Develops sepsis within 72 hours of ICU admission
• Voluntarily signs the informed consent form (or signed by the legal representative)
• Age ≥ 18 years
• Hospitalized in the ICU during the same period, with no clear evidence of infection and not meeting the diagnostic criteria for sepsis
• Expected ICU treatment time ≥ 24 hours
• Voluntarily signs the informed consent form (or signed by the legal representative)