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NCT06338111 Clinical Trial

Interventions Meant to Improve the Outcome of Critical Care Patients in the ED

Biomarker Clinical Trial

Official title:
A Bundle of Interventions Meant to Improve the Outcome of Critical Care Patients in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06338111
Other study ID # 2461
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 9, 2020
Est. completion date April 30, 2023

Study information
Verified date April 2024
Source Iuliu Hatieganu University of Medicine and Pharmacy
Contact n/a
Is FDA regulated No
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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