Prospective Observational Study to Evaluate the Diagnostic Accuracy of Presepsin for Sepsis in Severe Burn Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Dohern Kym
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Diagnostic sensitivity and specificity of presepsin for sepsis in severe burn patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Diagnostic sensitivity and specificity of presepsin for sepsis in severe burn patients
时间窗: 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.
次要结局
未报告次要终点
研究者
Dohern Kym
Attending Physician, Burn Intensive Care Unit
Hangang Sacred Heart Hospital