Sepsis Multiomic Analysis & Risk sTratification in China

NCT07599644 | Not Yet Recruiting

• 1 other identifier: China SMART-1
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives:

1. 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. 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. 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.

Conditions

Sepsis

Keywords

Sepsis; Early diagnosis; Biomarkers; RT-LAMP; ICU; Cohort study; Bulk RNA-seq

Outcome Measures

Primary Outcomes (4)

• 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.

  Within 24 hours of ICU admission (baseline)

• Results of sepsis molecular risk stratification, and differences in clinical characteristics, biological characteristics, and prognosis among different stratifications

  At baseline (within 24 hours of ICU admission)

• 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.

  At baseline (within 24 hours of ICU admission)

• 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.

  At baseline (within 24 hours of ICU admission

Secondary Outcomes (5)

• 28-day all-cause mortality, ICU length of stay, and incidence of new organ dysfunction in patients.

  28 days from baseline

• Correlation between mRNA expression levels and protein expression levels of core biomarkers and 28-day all-cause mortality and SOFA score in patients

  28 days from baseline

• Comparison results of diagnostic efficacy between novel biomarkers/combined diagnostic models and traditional indicators PCT and CRP.

  At baseline

• Subgroup analysis of biomarkers (infection site, pathogen type, organ injury)

  At baseline

• Analysis of immune inflammatory pathway characteristics of different molecular stratifications of sepsis.

  At baseline

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

Sponsors & Collaborators

• Yuebei People's Hospital: lead

Study Sites (1)

Yuebei People's Hospital

Shaoguan, Guangdong, 512026, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples and whole blood RNA (PAXgene tubes, 2.5 mL) collected within 24 hours of ICU admission and stored at -80 degrees Celsius. Plasma used for ELISA protein quantification; PAXgene RNA used for Bulk RNA-seq and RT-LAMP nucleic acid detection. RNA quality acceptance criteria: RNA Integrity Number of 6.0 or above.

MeSH Terms

Conditions

Sepsis; Disease

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pingsen Zhao Principal Investigator, Dr.

CONTACT

8613332876639; zhaopingsen01@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Technologist

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

CN (1)