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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Republic of Korea
Hangang Sacred Heart Hospital, Hallym University Medical Center
RECRUITING
Seoul
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 138
Related Therapeutic Areas
Sponsors
Leads: Dohern Kym

This content was sourced from clinicaltrials.gov