Presepsin Diagnostic Performance in Severe Burn Sepsis

NCT07060560 | Recruiting

• 1 other identifier: 2025-009
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Burns

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 2 hours after initial clinical suspicion of sepsis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A prospective cohort of adult (≥ 18 years) patients with severe burns (TBSA ≥ 20 %) admitted to the Burn Intensive Care Unit at Hangang Sacred Heart Hospital

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dohern Kym: lead

Study Sites (1)

Hangang Sacred Heart Hospital, Hallym University Medical Center

Seoul, Seoul, 07981, South Korea

RECRUITING

MeSH Terms

Conditions

Sepsis; Burns

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Burn Intensive Care Unit

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

KR (1)