This prospective diagnostic accuracy study evaluates the performance of presepsin and C-reactive protein (CRP) as early biomarkers for suspected sepsis in adult burn patients. From January 2021 to December 2022, 370 patients with ≥20% total body surface area burns admitted to the Burn Intensive Care Unit at Hallym University Hangang Sacred Heart Hospital were screened; 221 met inclusion criteria. At each clinical suspicion of sepsis (≥2 SIRS criteria), venous blood was drawn for simultaneous measurement of presepsin (via chemiluminescent immunoassay) and CRP (via immunoturbidimetric assay). Diagnostic accuracy will be quantified by sensitivity, specificity, positive/negative predictive values, and area under the ROC curve. The goal is to determine whether presepsin outperforms CRP for early sepsis detection in severe burn patients.
Age 18 years or older.
Admission to the Burn Intensive Care Unit (BICU) with a burn injury covering ≥10% of the Total Body Surface Area (TBSA).
Undergoing a blood culture due to clinical suspicion of sepsis (e.g., fever, abnormal white blood cell count, hemodynamic instability) during the ICU stay.
The participant or their legally authorized representative has provided written informed consent.
Pregnancy.
Pre-existing immunological conditions that, in the investigator's judgment, could interfere with biomarker interpretation (e.g., long-term use of immunosuppressants, congenital immunodeficiency).
Inability to participate at the time of study-related blood collection due to initial emergency surgery, major trauma, or significant hemorrhage.
Any other condition for which the principal investigator deems participation to be inappropriate or unsafe for the patient.
Adults (≥18 years) with severe thermal burns (TBSA ≥20%) admitted to a single-center BICU who developed clinically suspected sepsis (≥2 SIRS criteria) during the enrollment period; all participants underwent standardized blood sampling for presepsin and CRP assays
Cohort
Prospective
Not listed
Diagnostic accuracy of presepsin for early sepsis detection
Sensitivity and specificity of presepsin (measured by chemiluminescent immunoassay on PATHFAST analyzer) for diagnosing clinically suspected sepsis (≥2 SIRS criteria) in adult burn patients.
Area under the ROC curve (AUC) for presepsin versus CRP
Comparison of AUCs for presepsin and CRP using DeLong's test to assess which biomarker better discriminates sepsis versus non-sepsis.
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Dohern Kym
Lead sponsor
Hangang Sacred Heart Hospital
Sponsor institution
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