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Sepsis Multiomic Analysis & Risk sTratification in China (China SMART-1): A Prospective Observational Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Objectives: 1. Perform Bulk RNA-seq transcriptome sequencing on enrolled samples to screen sepsis-specific mRNA diagnostic biomarkers and evaluate their diagnostic efficacy for early sepsis in the ICU; establish a molecular risk stratification system for sepsis based on mRNA expression profiles, and clarify the immunobiological characteristics, clinical manifestation differences, and prognostic risk levels of each stratification. 2. Integrate core indicators screened from transcriptome sequencing, open-source databases, and previous studies to establish and optimize an RT-LAMP rapid detection method for core sepsis targets, validate its diagnostic accuracy, specificity, and reproducibility, and construct a rapid sepsis diagnostic model adapted to bedside scenarios. 3. Integrate core indicators screened from open-source databases and previous studies to screen sepsis-specific diagnostic biomarkers in plasma and urine via PRM and metabolomics, complete protein/metabolic level validation using immunological methods (ELISA), construct a combined diagnostic model for sepsis, and complete internal validation and efficacy evaluation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
Locations
Other Locations
China
Yuebei People's Hospital
RECRUITING
Shaoguan
Contact Information
Primary
Pingsen Zhao Principal Investigator, Dr.
zhaopingsen01@163.com
8613332876639
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 1400
Treatments
Sepsis group
Age \> 18 years; Meet the Sepsis-3 diagnostic criteria for sepsis: confirmed or suspected infection with an increase in SOFA score (Sequential Organ Failure Assessment) of ≥ 2 points from baseline; Develop sepsis within 72 hours of ICU admission; Voluntarily sign the informed consent form (or signed by the legal representative).
Non-sepsis control group
Age \> 18 years; Hospitalized in the ICU of our hospital 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 sign the informed consent form (or signed by the legal representative).
Related Therapeutic Areas
Sponsors
Leads: Yuebei People's Hospital

This content was sourced from clinicaltrials.gov