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Sepsis Multiomic Analysis & Risk sTratification in China

NCT07599644 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1400

Last updated 2026-07-10

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

  • Yuebei People's Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599644 on ClinicalTrials.gov