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Life sciences · Observational Study
ClinicalTrials.gov · September 16, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07822412). This is a study registration, not published results. Lead sponsor: Chang Gung Memorial Hospital. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 699 participants (ESTIMATED). Conditions: Sepsis, Septic Shock. Primary outcome measures: Diagnostic Accuracy of Presepsin for Early Sepsis Screening , At enrollment (Time 0 / Emergency Department presentation); Diagnostic Accuracy of Immature Granulocytes for Early Sepsis Screening , At enrollment (Time 0 / Emergency Department presentation). Brief summary: Early identification and timely intervention for sepsis in the emergency department (ED) are critical for improving patient outcomes. However, clinical diagnosis remains challenging due to the non-specific nature of early systemic symptoms. This study protocol aims to evaluate the diagnostic accuracy of a combined approach using Immature Granulocytes (IG) and Presepsin (sCD14-ST) for the early detection of sepsis in undifferentiated ED patients.