Sepsis Multiomic Analysis & Risk sTratification in China
ConditionSepsis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYuebei People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
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).
Disqualifiers
None
Trial population
Critically ill adult patients admitted to the ICU of Yuebei People's Hospital, Shaoguan, Guangdong, China. The study population includes patients with confirmed sepsis (Sepsis-3 criteria) and non-sepsis controls admitted during the same period. All participants had blood samples (plasma and whole blood RNA) and urine samples collected within 24 hours of ICU admission and stored at -80°C.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,400 Participants
are grouped into 2 trial groupsGroup A: Sepsis group
Group B: Non-sepsis control group
Trial outcomes
Primary outcomes
1
Whole-genome mRNA expression profiles of the sepsis group and the non-sepsis group, the list of core diagnostic biomarkers screened by multi-algorithm cross-validation (WGCNA + LASSO + SVM-RFE), and their diagnostic efficacy for early sepsis in the ICU.
Time frame
Within 24 hours of ICU admission (baseline)2
Results of sepsis molecular risk stratification, and differences in clinical characteristics, biological characteristics, and prognosis among different stratifications
Time frame
At baseline (within 24 hours of ICU admission)3
Methodological performance evaluation of the RT-LAMP rapid diagnostic method and its early diagnostic efficacy for sepsis, reporting AUC, sensitivity, specificity, positive/negative predictive values.
Time frame
At baseline (within 24 hours of ICU admission)4
Early diagnostic efficacy of protein/metabolic biomarkers in plasma/urine for sepsis, and AUC, sensitivity, specificity, positive/negative predictive values of the combined diagnostic model.
Time frame
At baseline (within 24 hours of ICU admissionSecondary outcomes
1
28-day all-cause mortality, ICU length of stay, and incidence of new organ dysfunction in patients.
Time frame
28 days from baseline2
Correlation between mRNA expression levels and protein expression levels of core biomarkers and 28-day all-cause mortality and SOFA score in patients
Time frame
28 days from baseline3
Comparison results of diagnostic efficacy between novel biomarkers/combined diagnostic models and traditional indicators PCT and CRP.
Time frame
At baseline4
Subgroup analysis of biomarkers (infection site, pathogen type, organ injury)
Time frame
At baselineSponsors and contacts
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Source ClinicalTrials.gov