Can we Improve Mortality Prediction in Patients With Sepsis in the Emergency Department

Biomarker Clinical Trial

Official title:

Can we Improve Mortality Prediction in Patients With Sepsis in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06338111
• Other study ID #: 2461
• Status: Completed
• Start date: November 9, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2024
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to identify the prognostic role of procalcitonin (PCT), soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1), the soluble form of the urokinase plasminogen activator receptor (suPAR), highly sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and azurocidin 1 (AZU1) in 28-day mortality for patients with sepsis in Emergency Department.

Description:

The levels of the specified biomarkers were measured upon patient arrival at the Emergency Department (ED) and analyzed their correlation with 28-day mortality. The values of these biomarkers were monitored over the initial three days following admission to the ED, aiming to explore their potential in guiding the de-escalation of antibiotic treatment. Considering their prognostic significance, the main goal is to develop a novel scoring system tailored for use in the emergency department setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 30, 2023
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Sepsis 3 Criteria

Exclusion Criteria:

• individuals aged under 18 or above 90

• pregnant women

• individuals in custody or deprived of their liberty

• patients with associated pathologies such as severe trauma

• other types of shocks

• acute stroke

• burns

• pancreatitis myocardial infarction, pulmonary edema, status asthmatics, convulsions, drug overdose, those requiring emergency surgery

• terminal stage of neoplastic disease

Related Conditions & MeSH terms

• Biomarker
• Emergencies
• Emergency Department
• Sepsis
• Sepsis Syndrome
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

Diagnostic Test:
• ELISA Sepsis Biomarkers dosage
Observational

Locations

Country	Name	City	State
Romania	Cluj County Hospital Emergency Department	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Can we better predict mortality in septic patients from the Emergency Department?	Evaluation of the prognostic role of : IL-6, sTREM-1, suPAR, AZU1, hsPCR and PCT in predicting 28-day mortality in Emergency Department	03.2024-05.2024