Presepsin Diagnostic Performance in Severe Burn Sepsis
Recruiting now
Conditions studied: Sepsis, Burns
In brief
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.
Key facts
- Study ID
- NCT07060560
- Run by
- Dohern Kym
- People needed
- 138
- Starts
- 2025-05-01
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-08-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged ≥ 18 years admitted to Hangang Sacred Heart Hospital Burn ICU with total body surface area (TBSA) ≥ 20 %
- Clinical suspicion of sepsis prompting blood culture and biomarker sampling
- Ability to understand the study and provide written informed consent (or via legally authorized representative)
You may not qualify if…
- Inability to undergo research blood draw due to emergent surgery or major trauma at sampling time
- Chronic immunosuppressive conditions (e.g., long-term high-dose steroids, organ transplant, congenital immunodeficiency)
- Pregnant women or those with significant psychiatric conditions precluding consent
- Any other medical or safety concerns deemed inappropriate by the investigator
Where it is running
- Hangang Sacred Heart Hospital, Hallym University Medical Center — Seoul, Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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