NCT07060560 Presepsin Diagnostic Performance in Severe Burn Sepsis
| NCT ID | NCT07060560 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dohern Kym |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 138 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 138 participants in total. It began in 2025-05-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT07060560 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07060560 currently recruiting?
Yes, NCT07060560 is actively recruiting participants. Visit ClinicalTrials.gov or contact Dohern Kym to inquire about joining.
Where is the NCT07060560 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07060560 clinical trial?
NCT07060560 is sponsored by Dohern Kym. The trial plans to enroll 138 participants.