[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yuebei People's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100643390","sepsis-multiomic-analysis--risk-stratification-in-china-100643390",false,"NCT07599644","Sepsis Multiomic Analysis & Risk sTratification in China","Sepsis Multiomic Analysis & Risk sTratification in China (China SMART-1): A Prospective Observational Cohort Study","China SMART-1","1. Inclusion Criteria for 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).\n2. Inclusion Criteria for Non-Sepsis 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).\n3. Exclusion Criteria Complicated with end-stage chronic organ failure (end-stage renal disease, decompensated liver cirrhosis (Child-Pugh Grade C), chronic heart failure NYHA Class IV), or malignant tumor; Immunocompromised or suffering from autoimmune diseases, or long-term use of glucocorticoids\u002Fimmunosuppressants within the past 3 months; Pregnant and postpartum patients; Patients with incomplete data collection; Other conditions deemed unsuitable for participation in the study by the investigator (such as terminal state, refusal to cooperate with sample collection, or inability to cooperate with in-hospital and out-of-hospital follow-up).","ALL","18 Years",{"count":20,"type":21},1400,"ESTIMATED","OBSERVATIONAL","Objectives:\n\n1. 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.\n2. 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.\n3. 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\u002Fmetabolic level validation using immunological methods (ELISA), construct a combined diagnostic model for sepsis, and complete internal validation and efficacy evaluation.",[25],"Sepsis",[25,27,28,29,30,31,32],"Early diagnosis","Biomarkers","RT-LAMP","ICU","Cohort study","Bulk RNA-seq","RECRUITING","2026-06-08",{"date":36,"type":37},"2026-06-11","ACTUAL",{"date":39,"type":37},"2026-06-01",{"date":41,"type":21},"2028-12-30",{"name":43,"class":44},"Yuebei People's Hospital","OTHER",""]