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Life sciences · Observational Study
ClinicalTrials.gov · October 5, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07060560). This is a study registration, not published results. Lead sponsor: Dohern Kym. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 138 participants (ESTIMATED). Conditions: Sepsis, Burns. Primary outcome measures: Diagnostic sensitivity and specificity of presepsin for sepsis in severe burn patients , Up to 2 hours after initial clinical suspicion of sepsis.. Brief summary: This study enrolls approximately 270 adult patients with severe burns covering at least 20% of total body surface area to evaluate how well the blood biomarker presepsin diagnoses sepsis early in this high-risk population. Sepsis-a life-threatening condition caused by an exaggerated immune response to infection-is particularly urgent to detect promptly in burn patients. Participants will undergo blood tests for presepsin at predefined time points, and these results will be compared to C-reactive protein (CRP), procalcitonin (PCT) levels, Sepsis-3 clinical criteria, and blood culture findings. The primary goal is to measure presepsin's sensitivity and specificity for sepsis detection, thereby determining its diagnostic accuracy. Findings from this study may enable faster sepsis treatment in severe burn patients and improve clinical outcomes.