Sepsis Multiomic Analysis & Risk sTratification in China

NCT07599644 | Recruiting

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

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.

Conditions

Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Diagnostic performance of the mRNA biomarker panel for early sepsis

  Whole-blood Bulk RNA-seq expression profiling of the sepsis versus non-sepsis groups. Core diagnostic mRNA biomarkers are selected by multi-algorithm cross-validation (WGCNA + LASSO + SVM-RFE). Diagnostic efficacy for early ICU sepsis is assessed against the Sepsis-3 reference classification and reported as AUC, sensitivity, specificity, PPV, and NPV.

  Within 24 hours of ICU admission (baseline)

• Number of sepsis molecular subtypes identified by unsupervised consensus clustering

  Unsupervised consensus clustering is applied to the sepsis-group whole-blood mRNA expression profiles; the optimal number of subtypes is determined by standard criteria (consensus CDF and delta-area). The reported value is the number of molecular subtypes identified. Unit of Measure: subtypes (count)

  Baseline (within 24 hours of ICU admission)

• Diagnostic accuracy (AUC) of the RT-LAMP assay for early sepsis

  The RT-LAMP assay targeting core sepsis mRNA markers is applied to whole-blood samples. Diagnostic accuracy for distinguishing sepsis from non-sepsis (against the Sepsis-3 reference classification) is summarized by the area under the ROC curve (AUC). Sensitivity, specificity, PPV, and NPV at the optimal cut-off are reported as supporting measures in the Description. Unit of Measure: AUC (0-1)

  Within 24 hours of ICU admission (baseline)

• Diagnostic accuracy (AUC) of the combined protein/metabolic biomarker model for sepsis

  Plasma/urine protein biomarkers (measured by PRM/ELISA) and metabolic biomarkers are combined by multivariable logistic regression into a multi-marker diagnostic model. Diagnostic accuracy for distinguishing sepsis from non-sepsis (against the Sepsis-3 reference classification) is summarized by the area under the ROC curve (AUC). Sensitivity, specificity, PPV, and NPV at the optimal cut-off are reported as supporting measures in the Description. Unit of Measure: AUC (0-1)

  Within 24 hours of ICU admission (baseline)

Secondary Outcomes (7)

• 28-day all-cause mortality

  28 days from baseline

• ICU length of stay

  From ICU admission through ICU discharge, up to 28 days

• Incidence of new-onset organ dysfunction

  Through 28 days from baseline

• Correlation of core biomarker expression with 28-day mortality and SOFA score

  28 days from baseline

• Comparative diagnostic performance versus PCT and CRP

  Within 24 hours of ICU admission (baseline)

Study Arms (2)

Sepsis group

Adult ICU patients (≥18 years) meeting Sepsis-3 criteria (confirmed or suspected infection with an acute rise in SOFA ≥ 2), with sepsis onset within 72 hours of ICU admission.

Non-sepsis control group

Adult ICU patients (≥18 years) admitted during the same period with no clear evidence of infection, not meeting sepsis criteria, and an expected ICU stay ≥ 24 hours.

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.

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yuebei People's Hospital: lead

Study Sites (1)

Yuebei People's Hospital

Shaoguan, Guangdong, 512026, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood (PAXgene tubes, \~2.5 mL) and urine are collected for research within 24 hours of ICU admission; residual plasma from routine clinical testing is also retained. All samples are stored at -80°C. Plasma and urine are used for targeted proteomics (PRM), high-throughput targeted metabolomics, and ELISA protein quantification. PAXgene whole-blood RNA is used for bulk RNA-seq and RT-LAMP nucleic acid detection. RNA quality acceptance criterion: RNA Integrity Number (RIN) ≥ 6.0.

MeSH Terms

Conditions

Sepsis; Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Principal Investigator

CONTACT

8613923034950; 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: June 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CN (1)