Presepsin blood test for early sepsis detection in severe burn patients
Official title: Prospective Observational Study to Evaluate the Diagnostic Accuracy of Presepsin for Sepsis in Severe Burn Patients
Run by Hangang Sacred Heart Hospital · NCT07060560 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 138 (estimated) |
| Sponsor | Hangang Sacred Heart Hospital Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07060560 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other ICU studies have shown promising results for presepsin as a sepsis biomarker, but large-scale data specifically in severe burn populations remain limited.
Who can join: the full rules
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 it's running
-
Hangang Sacred Heart Hospital, Hallym University Medical Center
Seoul, Seoul, South Korea Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.