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

April 15, 2024 updated by: Sonia Luka, Iuliu Hatieganu University of Medicine and Pharmacy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Cluj County Hospital Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Sepsis or septic shock patients admitted to ED

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
09.11.2020-01.08.2021, patients with sepsis and septic shock
Diagnostic test: ELISA Sepsis Biomarkers dosage
Observational
Other Names:
  • ELISA Specific Sepsis Biomarkers dosage
2
13.07.2022-04.12.2022, patients with sepsis and septic shock
Diagnostic test: ELISA Sepsis Biomarkers dosage
Observational
Other Names:
  • ELISA Specific Sepsis Biomarkers dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Can we better predict mortality in septic patients from the Emergency Department?
Time Frame: 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
03.2024-05.2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2020

Primary Completion (Actual)

December 6, 2022

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

March 23, 2024

First Submitted That Met QC Criteria

March 23, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2461

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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