Sepsis Multiomic Analysis & Risk sTratification in China

Sponsor
Yuebei People's Hospital
Study ID
NCT07599644
Status
Recruiting
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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
May 20, 2026
Start date
Jun 1, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
1,400 participants (estimated)

Arms

  • Arm: Sepsis group
    Adult ICU patients (≥18 years) meeting Sepsis-3 criteria (confirmed or suspected infection with an acute rise in SOFA ≥ 2), with sepsis onset within 72 hours of ICU admission.
  • Arm: Non-sepsis control group
    Adult ICU patients (≥18 years) admitted during the same period with no clear evidence of infection, not meeting sepsis criteria, and an expected ICU stay ≥ 24 hours.

Primary Outcome Measure

Diagnostic performance of the mRNA biomarker panel for early sepsis [ Time Frame: Within 24 hours of ICU admission (baseline) ]

Central Contacts

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