Neutrophil EMR3 as a biomarker for sepsis in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective observational study will enroll about 3,000 adults across 8-15 hospitals in China. Neutrophil EMR3 (ADGRE3) expression will be measured from residual blood samples using standardized flow cytometry to evaluate its association with sepsis diagnosis, immune response, and prognosis. Participants will include those with sepsis, septic shock, infection without sepsis, noninfectious critical illness, and controls. An independent adjudication committee, blinded to EMR3 results, will classify sepsis status per Sepsis-3 criteria. Longitudinal EMR3 measurements will be analyzed alongside clinical severity, organ dysfunction, and inflammatory biomarkers to determine potential utility.

Why it matters

Who can join: the full rules

\*\*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.

Where it's running

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

Study contacts

• Principal investigator: Zhou Jiancang — Sir Run Run Shaw Hospital
• Study coordinator: Zhou Jiancang
• Email: jiancangzhou@zju.edu.cn
• Phone: +86 13867413145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.