NCT07060560

Presepsin Diagnostic Performance in Severe Burn Sepsis

Prospective Observational Study to Evaluate the Diagnostic Accuracy of Presepsin for Sepsis in Severe Burn Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: Dohern Kym · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Burns

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-07-11
• Last updated: 2025-08-11

Locations

1 site across 1 country: South Korea