Use of Presepsin in the Emergency Department

NCT06150092 | Unknown

• 1 other identifier: 5984
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sepsis

Keywords

suspected sepsis; early diagnosis of sepsis

Outcome Measures

Primary Outcomes (1)

• Role of serum dosage of presepsin

  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

  3 days

Secondary Outcomes (1)

• Presepsin as a biomarker prognosticator and predictor of mortality

  30 days

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

All consecutive patients entering the emergency department with symptoms suggestive of sepsis will be included in the study if they are of age, not pregnant who meet the predetermined inclusion criteria. The blood draw required for the presepsin assay will occur at the same time as the blood draws required for routine testing, according to intrahospital guidelines.

You may qualify if:

• 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.

You may not qualify if:

• Age \<18 years;
• Pregnant women
• Refusal to sign written informed consent to participation in the study and the processing of personal data

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario "A. Gemelli" IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andrea Piccioni, Dr.

CONTACT

0630153161; andrea.piccioni@policlinicogemelli.it

Alessandra Bronzino, Dott. ssa

CONTACT

+393497383972; alessandra.bronzino@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 29, 2023
• Study Start: October 10, 2023
• Primary Completion: October 10, 2024
• Study Completion: April 10, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)