Clinical Trial

Evaluating the Accuracy of Multiple Blood Tests to Diagnose Sepsis in Adult Burn Patients

Study acronym: BioBurnSepsis
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Summary
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.
Trial Details
NCT Number NCT07126574
Lead Sponsor Dohern Kym
Conditions Sepsis - to Reduce Mortality in the Intensive Care Unit, Burns Involving 20% or More of Body Surface
Enrollment 165 participants
Start Date 2025-08-15
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-17