NCT07599644 Sepsis Multiomic Analysis & Risk sTratification in China
| NCT ID | NCT07599644 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yuebei People's Hospital |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,400 participants in total. It began in 2026-06-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria - Sepsis Group: * 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) Inclusion Criteria - Non-Sepsis Group: * 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) Exclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07599644 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07599644 currently recruiting?
Yes, NCT07599644 is actively recruiting participants. Contact the research team at zhaopingsen01@163.com for enrollment information.
Where is the NCT07599644 trial being conducted?
This trial is being conducted at Shaoguan, China.
Who is sponsoring the NCT07599644 clinical trial?
NCT07599644 is sponsored by Yuebei People's Hospital. The trial plans to enroll 1,400 participants.