Use of Presepsin in the Emergency Department - Trial NCT06150092

Timeline & Enrollment

Primary Outcome

Role of serum dosage of presepsin

Summary

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).

ICD-10 Classifications