Research Protocol for Evaluating the Diagnostic Utility of SAA, Procalcitonin, Presepsin, CRP, and Routine Blood Biomarkers in Adult Burn Patients With Sepsis in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 主要终点
- Diagnostic accuracy of presepsin for early sepsis detection
研究概览
简要总结
This prospective diagnostic accuracy study evaluates the performance of presepsin and C-reactive protein (CRP) as early biomarkers for suspected sepsis in adult burn patients. From January 2021 to December 2022, 370 patients with ≥20% total body surface area burns admitted to the Burn Intensive Care Unit at Hallym University Hangang Sacred Heart Hospital were screened; 221 met inclusion criteria. At each clinical suspicion of sepsis (≥2 SIRS criteria), venous blood was drawn for simultaneous measurement of presepsin (via chemiluminescent immunoassay) and CRP (via immunoturbidimetric assay). Diagnostic accuracy will be quantified by sensitivity, specificity, positive/negative predictive values, and area under the ROC curve. The goal is to determine whether presepsin outperforms CRP for early sepsis detection in severe burn patients.
详细描述
Background and Rationale Sepsis is a leading cause of mortality in patients with severe burns, yet its early diagnosis is challenging. The systemic inflammatory response triggered by the burn injury itself often mimics the clinical signs of sepsis, confounding diagnosis and leading to delayed or unnecessary antibiotic use. Conventional biomarkers like C-reactive protein (CRP) and procalcitonin (PCT) lack specificity in this population, as they are elevated by the sterile inflammation from the burn itself. This study aims to overcome these limitations by evaluating the diagnostic utility of a multi-biomarker panel, analyzing their dynamic changes over time, and leveraging machine learning to develop a more accurate and interpretable diagnostic model for sepsis in burn patients.
Study Design and Objectives This is a single-center, prospective observational cohort study conducted at the Burn Intensive Care Unit (BICU) of Hallym University Hangang Sacred Heart Hospital. The study will run from September 2025 to August 2026.
Primary Objective: To evaluate the diagnostic accuracy (sensitivity, specificity, AUC) of a multi-biomarker panel-comprising Serum Amyloid A (SAA), Procalcitonin (PCT), Presepsin (PSP), and CRP-for diagnosing sepsis in adult burn patients, using the Sepsis-3 criteria as the reference standard.
Secondary Objectives: To compare the diagnostic performance of the multi-biomarker panel against individual biomarkers and standard clinical severity scores (e.g., SOFA score).
To assess the panel's ability to predict disease severity and mortality (28-day and 90-day).
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
- •Age 18 years or older.
- •Admission to the Burn Intensive Care Unit (BICU) with a burn injury covering ≥10% of the Total Body Surface Area (TBSA).
- •Undergoing a blood culture due to clinical suspicion of sepsis (e.g., fever, abnormal white blood cell count, hemodynamic instability) during the ICU stay.
- •The participant or their legally authorized representative has provided written informed consent.
排除标准
- •Pregnancy.
- •Pre-existing immunological conditions that, in the investigator's judgment, could interfere with biomarker interpretation (e.g., long-term use of immunosuppressants, congenital immunodeficiency).
- •Inability to participate at the time of study-related blood collection due to initial emergency surgery, major trauma, or significant hemorrhage.
- •Any other condition for which the principal investigator deems participation to be inappropriate or unsafe for the patient.
结局指标
主要结局
Diagnostic accuracy of presepsin for early sepsis detection
时间窗: At the time of clinical suspicion of sepsis (Day 0), and daily for the following 7 days (Day 1 through Day 7).
Sensitivity and specificity of presepsin (measured by chemiluminescent immunoassay on PATHFAST analyzer) for diagnosing clinically suspected sepsis (≥2 SIRS criteria) in adult burn patients.
次要结局
- Area under the ROC curve (AUC) for presepsin versus CRP(Through study completion, an average of 1.5 years.)
研究者
Dohern Kym
Attending Physician, Burn Intensive Care Unit
Hangang Sacred Heart Hospital