Presepsin Diagnostic Performance in Severe Burn Sepsis

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.

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Key information

Conditions

Sepsis Burns Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangang Sacred Heart Hospital, Hallym University Medical Center

Seoul, 07981, South Korea

Location status: Recruiting

Location contact

Dohern

CONTACT

Ra Gyeom Seong

CONTACT

[email protected]

01094157154

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Diagnostic sensitivity and specificity of presepsin for sepsis in severe burn patients

Time frame: Up to 2 hours after initial clinical suspicion of sepsis.

The proportion of true-positive and true-negative presepsin results for diagnosing sepsis using Sepsis-3 clinical criteria and positive blood culture as the reference standard.

Sponsors and collaborators

Lead sponsor

Dohern Kym

Other

Registry information

Official study title

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

Acronym: PSEP-BURNS

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 11, 2025
Registry last updated: Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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