Using Presepsin to Diagnose Sepsis in the Emergency Department
Use of Presepsin for Early Diagnosis of Sepsis in the Emergency Room
This study is testing if a blood test called Presepsin can help doctors quickly diagnose sepsis in patients coming to the emergency department.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06150092 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of Presepsin as a biomarker for diagnosing sepsis in patients presenting to the emergency department with suspected sepsis. It will involve the enrollment of 300 consecutive patients who meet specific eligibility criteria, with blood samples collected for Presepsin testing alongside routine tests. The study will last 18 months, with the first 12 months dedicated to patient enrollment and the subsequent 6 months for data analysis and reporting. The goal is to determine the diagnostic accuracy of Presepsin in identifying sepsis early in emergency settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who present to the emergency department with symptoms suggestive of sepsis.
Not a fit: Patients under 18 years of age, pregnant women, or those who refuse to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of sepsis, potentially reducing mortality rates associated with this condition.
How similar studies have performed: While the use of Presepsin as a diagnostic tool is being explored, this specific approach in the emergency department setting is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Age \<18 years; * Pregnant women * Refusal to sign written informed consent to participation in the study and the processing of personal data
Where this trial is running
Roma
- Fondazione Policlinico Universitario "A. Gemelli" IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Andrea Piccioni, Dr.
- Email: andrea.piccioni@policlinicogemelli.it
- Phone: 0630153161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.