Loading
Life sciences · Observational Study
ClinicalTrials.gov · October 26, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07896018). This is a study registration, not published results. Lead sponsor: Sir Run Run Shaw Hospital. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 3000 participants (ESTIMATED). Conditions: Sepsis. Primary outcome measures: Diagnostic Accuracy of Neutrophil EMR3 Expression for Sepsis , At baseline (T0), within 6 hours of enrollment or initial ICU admission.. Brief 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.