Presepsin blood test for early sepsis detection in severe burn patients
Prospective Observational Study to Evaluate the Diagnostic Accuracy of Presepsin for Sepsis in Severe Burn Patients
This project will test whether a blood marker called presepsin can detect sepsis early in adults who have severe burns covering at least 20% of their body.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hangang Sacred Heart Hospital Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT07060560 on ClinicalTrials.gov |
What this trial studies
About 270 adults with severe burns (≥20% total body surface area) admitted to a burn ICU will be enrolled and have blood taken at predefined time points. Researchers will measure presepsin levels and compare them with C-reactive protein, procalcitonin, Sepsis-3 clinical criteria, and blood culture results. The primary outcome is presepsin's sensitivity and specificity for diagnosing sepsis in this high-risk population. The observational design aims to determine whether presepsin offers earlier or more accurate sepsis detection than standard markers.
Who should consider this trial
Good fit: Adults aged 18 or older with severe burns covering at least 20% of total body surface area who are admitted to the Hangang Sacred Heart Hospital burn ICU and have clinical suspicion of sepsis are ideal candidates.
Not a fit: Patients who are chronically immunosuppressed, pregnant, unable to undergo blood draws during emergency surgery or major trauma, or who do not have suspected sepsis are unlikely to gain direct benefit from this study.
Why it matters
Potential benefit: If presepsin proves accurate, clinicians could detect sepsis sooner in severe burn patients and start treatment earlier, potentially reducing complications and deaths.
How similar studies have performed: Other ICU studies have shown promising results for presepsin as a sepsis biomarker, but large-scale data specifically in severe burn populations remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 this trial is running
Seoul, Seoul
- Hangang Sacred Heart Hospital, Hallym University Medical Center — Seoul, Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.