Sepsis Multiomic Analysis & Risk sTratification in China

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.

NCT Number	NCT07599644
Lead Sponsor	Yuebei People's Hospital
Conditions	Sepsis
Enrollment	1,400 participants
Start Date	2026-06-01
Primary Completion	2027-12-30 (estimated)
Study Completion	2028-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-10