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

NCT06338111 | Completed

• 1 other identifier: 2461
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis Syndrome; Emergency Department; Biomarker

Keywords

Procalcitonin; Azurocidin 1; High Sensitivity C reactive protein; Urokinase-type plasminogen activator system; Soluble triggering receptor expressed on myeloid cells - 1; Interleukin-6; Severity scores; Emergency Department; Sepsis; Septic shock

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

09.11.2020-01.08.2021, patients with sepsis and septic shock

Diagnostic Test: ELISA Sepsis Biomarkers dosage

2

13.07.2022-04.12.2022, patients with sepsis and septic shock

Diagnostic Test: ELISA Sepsis Biomarkers dosage

Interventions

ELISA Sepsis Biomarkers dosage DIAGNOSTIC_TEST

Observational

Also known as: ELISA Specific Sepsis Biomarkers dosage

1; 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sepsis or septic shock patients admitted to ED

You may qualify if:

• Sepsis 3 Criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Cluj County Hospital Emergency Department

Cluj-Napoca, Cluj, 400006, Romania

Location

Biospecimen

Retention: SAMPLES WITH DNA

biochemistry blood samples

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Emergencies; Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant PhD Student Sonia Luka

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: March 29, 2024
• Study Start: November 9, 2020
• Primary Completion: December 6, 2022
• Study Completion: April 30, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

RO (1)