Sepsis Multiomic Analysis & Risk sTratification in China
Recruiting now
Conditions studied: Sepsis
In brief
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.
Key facts
- Study ID
- NCT07599644
- Run by
- Yuebei People's Hospital
- People needed
- 1400
- Starts
- 2026-06-01
- Expected to finish
- 2028-12-30
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- End-stage chronic organ failure (end-stage renal disease, decompensated liver cirrhosis [Child-Pugh Grade C], or chronic heart failure NYHA Class IV), or malignant tumor
- Immunocompromised, autoimmune disease, or long-term use of glucocorticoids/immunosuppressants within the past 3 months
- Pregnant or postpartum patients
- Other conditions deemed unsuitable by the investigator (e.g., terminal state, refusal to cooperate with sample collection, or inability to cooperate with in-hospital and out-of-hospital follow-up)
Where it is running
- Yuebei People's Hospital — Shaoguan, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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