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Clinical Trials in China / NCT07896018
Recruiting Observational

Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study

NCT07896018 · tracked via the Priya Life Science China tracker
Sponsor
Sir Run Run Shaw Hospital
Phase
Observational
Started
2026-11
Last updated
2026-10-28

Condition(s) studied

Sepsis

Study summary

Sepsis is a life-threatening condition caused by a dysregulated immune response to infection, leading to organ dysfunction and increased mortality. Early diagnosis and accurate assessment of disease progression remain challenging. EMR3 (ADGRE3), a receptor expressed on the surface of neutrophils, may serve as a potential biomarker for sepsis diagnosis, immune response monitoring, and prognosis assessment. However, its clinical value requires further validation in large, multicenter prospective studies.

This multicenter, prospective, observational study will enroll approximately 3,000 adults across 8-15 hospitals in China. Participants will be classified into four groups: patients with sepsis or septic shock, patients with infection without sepsis, patients with noninfectious critical illnesses, and healthy or elective surgical controls. Neutrophil EMR3 expression will be measured using flow cytometry on residual blood samples obtained during routine clinical care. Patients with sepsis will undergo repeated measurements at baseline, 72 ± 12 hours, and day 7 ± 1 day, with an optional assessment at day 14 ± 2 days. Other participants will undergo baseline testing only. All participants will receive standard clinical care without study-related interventions or additional blood collection.

The primary outcome is the diagnostic accuracy of baseline neutrophil EMR3 expression for identifying sepsis, assessed by the area under the receiver operating characteristic curve (AUC). Secondary outcomes include changes in EMR3 expression over time, associations with 28-day all-cause mortality, septic shock, organ dysfunction, secondary infections, and intensive care unit length of stay. The study will also compare EMR3 with established biomarkers, including CD64, HLA-DR, procalcitonin, C-reactive protein, and lactate, and evaluate whether incorporating EMR3 into combined models improves diagnostic and prognostic performance. This study aims to determine whether neutrophil EMR3 can serve as a reliable biomarker for early sepsis diagnosis, disease monitoring, and risk stratification.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
\*\*Inclusion Criteria:\*\* * Age ≥18 years. * Patients admitted for the first time to the ICU or emergency ICU (EICU) of a participating center during the study period, including patients with suspected or confirmed infection, sepsis, septic shock, or noninfectious critical illness. Healthy volunteers undergoing routine health examinations may also be included as controls. * Availability of residual EDTA-anticoagulated whole blood from routine clinical testing at enrollment, suitable for flow cytometry within the predefined testing window. * Provision of written informed consent by the participant or a legally authorized representative, with an independent witness when required. * Ability to complete baseline clinical data collection and 28-day outcome follow-up, as determined by the investigator. * Expected survival of more than 72 hours. \*\*Exclusion Criteria:\*\* * Receipt of chemotherapy, chimeric antigen receptor T-cell (CAR-T) therapy, hematopoietic stem cell transplantation, or high-dose immunosuppressive therapy within 30 days before enrollment. Participants included in a predefined exploratory immunosuppression subgroup will be excluded from the primary diagnostic analysis. * Active hematological malignancy, severe granulocytopenia, or absolute neutrophil count \<0.5 × 10⁹/L that may interfere with the interpretation of myeloid cell phenotypes. * Known uncontrolled HIV infection, systemic lupus erythematosus, or long-term systemic corticosteroid or immunomodulatory therapy considered by the investigator to substantially affect the primary analysis. * Pregnancy or breastfeeding. * Severely hemolyzed or clotted blood samples, sample identification errors, processing beyond the permitted time window, or missing critical clinical data preventing outcome adjudication. * Refusal by the participant or legally authorized representative to permit the use of residual blood samples and clinical data. * Expected survival of less than 72 hours. * A documented decision by the participant or family to withhold or limit active treatment. * Membership in vulnerable populations other than those specifically permitted by the protocol (patients with cognitive impairment, critically ill patients, older adults, and individuals unable to read), including individuals with psychiatric disorders.

Primary outcome measure(s)

  • Diagnostic Accuracy of Neutrophil EMR3 Expression for Sepsis — At baseline (T0), within 6 hours of enrollment or initial ICU admission.
    The diagnostic accuracy of baseline neutrophil EMR3 expression for identifying sepsis will be evaluated using the area under the receiver operating characteristic curve (ROC-AUC), with a 95% confidence interval. EMR3 expression will be measured by flow cytometry using residual EDTA-anticoagulated whole blood. The primary comparison will be between patients with sepsis or septic shock and patients with infection without sepsis or noninfectious critical illness. Healthy or elective surgical controls will be excluded from the primary diagnostic comparison.

Trial sites (1)

FacilityCityRegionStatus
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

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Other trials for the same condition

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Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions（EXIT-SEP REAL） Starting soon
AN69ST Verse PS in CBP in Septic Children Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07896018 on ClinicalTrials.gov ↗ ← All trials in China