Use of Presepsin for Early Diagnosis of Sepsis in the Emergency Room
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Role of serum dosage of presepsin
研究概览
简要总结
Sepsis is an extremely common systemic condition in the Emergency Room (ER), which is found to be to be one of the leading causes of death among patients accessing the ER.
To date, the diagnosis of sepsis does not rely on any specific markers for infectious conditions, but several methods of assessing the general condition of the patient, namely markers that elevate in a variety of inflammatory conditions (PCR, PCT), indices of tissue hypoxia (serum lactate), and scores based on the haemochromocytometric examination, the markers of function of different organs, and vital parameters expressed by the patient at the time of assessment (SOFA, qSOFA, SIRS, NEWS). These markers, in addition to not be specific for sepsis, have an insufficiently early peak of presentation to readily identify all patients presenting with this condition.
Presepsin, as the N-terminal portion of the soluble component of Cluster of Differentiation 14 (CD14), is elevated almost exclusively in infectious conditions; moreover, its elevation in infectious contexts is extremely early compared with that of markers already in use, allowing early identification of septic patients who to date would be recognized as such only hours after the onset of the septic process. In addition, the determination of this biomarker could make it possible to stratify patients by prognosis, allowing greater attention to be paid to the most severe patients.
It is hypothesized that the Presepsin assay in emergency room will allow to increase the rapidity and specificity of sepsis diagnosis compared with the diagnostic procedure currently used, improving the outcomes of patients accessing the emergency room with symptoms suggestive of sepsis.
The main purpose of the present study is to evaluate the role of serum assay of presepsin in the early diagnosis of sepsis in patients presenting to the emergency department with clinical suspicion of sepsis by comparing the values obtained with traditionally used such as PCR, PCT, and blood culture. The secondary objective is to evaluate presepsin as a prognostic biomarker and useful for mortality risk stratification of the same patients, comparing the values obtained with validated predictor scores of mortality and/or severity (APACHEII, SOFA, qSOFA).
详细描述
Study design: Prospective observational study without drug or device
Sample definition: 300 consecutive patients will be included in the study who enter the emergency department with symptoms suggestive of sepsis and who meet the criteria for eligibility. The blood sampling required for the presepsin assay will take place concurrently with the blood draws required for routine testing. Assuming that approximately 70 percent of patients will have a confirmed diagnosis of sepsis and assuming an Area Under the Roc Curve (AUC) of 0.80 this number of patients will allow the AUC of presepsin dosing to be estimated with a 95% confidence interval of overall magnitude of 0.10, thus obtaining an estimate interval from 0.75 to 0.85
Duration of the study: The duration of the study will be 18 months from the approval of the this protocol by the Territorial Ethics Committee (TEC). The enrollment phase of the patients will last 12 months, while the next 6 months will be devoted to data extraction, statistical analysis and scientific reporting.
Procedures: Prospectively enrolled patients will be selected by the attending physician at the time of the first visit and, if eligible, will be asked for written informed consent to participation in the study. Patients will be enrolled during emergency evaluation as part of standard care in the EM, and during blood draws as required by clinical practice routine practice a venous blood sample will be taken at the time of the visit. It will be performed serum analysis and presepsin assay obtained, without additional blood draws.
Variables of interest:
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
- •Patients aged ≥18 years;
- •Patients presenting to the emergency department with suspected clinical sepsis
- •Patients who submit at the time of the visit will have a venous blood sample taken.
- •Signature of written informed consent to participate to the study and the processing of personal data.
排除标准
- •Age <18 years;
- •Pregnant women
- •Refusal to sign written informed consent to participation in the study and the processing of personal data
结局指标
主要结局
Role of serum dosage of presepsin
时间窗: 3 days
To evaluate the role of serum dosage of presepsin in the early diagnosis of sepsis in patients presenting to the emergency department with clinical suspicion of sepsis by comparing the values obtained with biomarkers traditionally used
次要结局
- Presepsin as a biomarker prognosticator and predictor of mortality(30 days)
研究者
Piccioni Andrea
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS