Sepsis SyndromeNCT06338111
Can we Improve Mortality Prediction in Patients With Sepsis in the Emergency Department
An observational study of Sepsis Syndrome and Emergency Department, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis Syndrome, Emergency Department, Biomarker
- What is being tested?
- ELISA Sepsis Biomarkers dosage
- How many people
- 67 participants
- Where
- 1 siteRomania
- Study dates
- 9 Nov 2020to 30 Apr 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sepsis or septic shock patients admitted to ED
Who may be able to join
- Sepsis 3 Criteria
Who cannot join
- 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
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- burns
- pancreatitis myocardial infarction, pulmonary edema, status asthmatics, convulsions, drug overdose, those requiring emergency surgery
- terminal stage of neoplastic disease
Trial locations and contacts
1 site in 1 country.
Romania1 site
Cluj County Hospital Emergency Department
Cluj-Napoca, Cluj, 400006
About this study
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.
Read the 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.
- Conditions
- Sepsis Syndrome, Emergency Department, Biomarker
- Being tested
- ELISA Sepsis Biomarkers dosage
- 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
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Emergencies, Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA Sepsis Biomarkers dosageDiagnostic test
Also called ELISA Specific Sepsis Biomarkers dosage
Observational
| Study group | Role | What they receive |
|---|---|---|
| 1 | 09.11.2020-01.08.2021, patients with sepsis and septic shock Receives: Diagnostic Test: ELISA Sepsis Biomarkers dosage | |
| 2 | 13.07.2022-04.12.2022, patients with sepsis and septic shock Receives: Diagnostic Test: ELISA Sepsis Biomarkers dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 03.2024-05.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start9 Nov 2020
- Primary completion6 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Luka, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338111
- Sponsor's protocol ID
- 2461
- Status last verified
- Jun 2024
- First submitted
- 23 Mar 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No