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.
Age: Adult patients (≥ 18 years old) presenting to the EDs of the participating sites.
Clinical Suspicion of Infection: A high clinical suspicion of infection as determined by the attending emergency physician, accompanied by either a Systemic Inflammatory Response Syndrome (SIRS) score ≥ 2 or a Quick Sequential Organ Failure Assessment (qSOFA) score ≥ 2.
Feasibility of Biomarker Collection: Ability to obtain blood samples for IG and Presepsin measurement within 2 hours of ED arrival.
Informed Consent: Provision of written informed consent obtained from the patient or their legally authorized representative (LAR).
Severe Immunosuppression: Active chemotherapy, history of organ transplantation, or long-term high-dose corticosteroid therapy that may confound leukocyte kinetics or suppress systemic inflammatory responses.
Hematological Conditions: Documented hematological malignancies or myelodysplastic syndromes (MDS) capable of altering baseline IG profiles.
Pregnancy or lactation, due to the potential for pregnancy-induced physiological and immunological variability.
Prolonged Prior Hospitalization: Patients transferred from another facility after an admission of >24 hours, as extensive prior intervention may obscure the hyper-acute biomarker kinetics critical for early diagnosis.
The study population consists of adult patients (aged 18 years and older) who present to the emergency department of participating multi-center medical institutions with a suspected or confirmed infection and exhibit clinical signs suggestive of early sepsis.
Cohort
Prospective
Not listed
Diagnostic Accuracy of Presepsin for Early Sepsis Screening
The diagnostic performance of Presepsin (measured in pg/mL) will be evaluated using the Area Under the Receiver Operating Characteristic curve (AUROC). The AUROC will be analyzed to evaluate the ability of Presepsin to differentiate patients with sepsis from those with non-infectious systemic inflammatory response syndrome (SIRS).
Diagnostic Accuracy of Immature Granulocytes for Early Sepsis Screening
The diagnostic performance of immature granulocytes (IG, measured in percentage) will be evaluated using the Area Under the Receiver Operating Characteristic curve (AUROC). The AUROC will be analyzed to evaluate the ability of IG to differentiate patients with sepsis from those with non-infectious systemic inflammatory response syndrome (SIRS).
Prognostic Value of Presepsin for Predicting Septic Shock Development
Evaluation of the capability of Presepsin (measured in pg/mL) to predict progression from early sepsis to septic shock. The prognostic performance will be analyzed by calculating the AUROC, sensitivity, specificity, positive predictive value, and negative predictive value.
Prognostic Value of Immature Granulocytes for Predicting Septic Shock Development
Evaluation of the capability of immature granulocytes (IG, measured in percentage) to predict progression from early sepsis to septic shock. The prognostic performance will be analyzed by calculating the AUROC, sensitivity, specificity, positive predictive value, and negative predictive value.
Concentration of Presepsin for Predicting 30-Day All-Cause Mortality
Concentration of Presepsin (measured in pg/mL) used to assess the 30-day all-cause mortality rate post-enrollment. The prognostic performance will be evaluated by calculating the Area Under the Receiver Operating Characteristic curve (AUROC) and the Odds Ratio (OR) derived from multiple logistic regression analysis to determine the predictive capability of Presepsin for 30-day mortality.
Percentage of Immature Granulocytes for Predicting 30-Day All-Cause Mortality
Percentage of immature granulocytes (measured in percentage, %) used to assess the 30-day all-cause mortality rate post-enrollment. The prognostic performance will be evaluated by calculating the Area Under the Receiver Operating Characteristic curve (AUROC) and the Odds Ratio (OR) derived from multiple logistic regression analysis to determine the predictive capability of immature granulocytes for 30-day mortality.
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