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

Completed

• Conditions: Emergency Department; Biomarker; Sepsis Syndrome
• Interventions: Diagnostic Test: ELISA Sepsis Biomarkers dosage

• Registration Number: NCT06338111
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-11-09
• Primary Completion: 2022-12-06
• Study Completion: 2023-04-30
• Study First Submitted: 2024-03-23
• Study First Submitted QC: 2024-03-23
• Study First Posted: 2024-03-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	ELISA Sepsis Biomarkers dosage	09.11.2020-01.08.2021, patients with sepsis and septic shock
2	ELISA Sepsis Biomarkers dosage	13.07.2022-04.12.2022, patients with sepsis and septic shock

Primary Outcome Measures

Name	Time	Method
Can we better predict mortality in septic patients from the Emergency Department?	03.2024-05.2024	Evaluation of the prognostic role of : IL-6, sTREM-1, suPAR, AZU1, hsPCR and PCT in predicting 28-day mortality in Emergency Department

Trial Locations

Locations (1)

Cluj County Hospital Emergency Department; 🇷🇴 Cluj-Napoca, Cluj, Romania