Can we Improve Mortality Prediction in Patients With Seps... | NCT06338111

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

NCT06338111

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Status

Completed

Last Update Posted

Jun 7, 2024Actual

Enrollment

67Actual

Phase

Not provided

Conditions

Sepsis Syndrome
Emergency Department
Biomarker

Interventions

ELISA Sepsis Biomarkers dosage

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 9, 2020Actual

Primary Completion Date

Dec 6, 2022Actual

Completion Date

Apr 30, 2023Actual

First Submitted Date

Mar 23, 2024

First Submission Date that Met QC Criteria

Mar 23, 2024

First Posted Date

Mar 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2024

Last Update Posted Date

Jun 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sonia Luka, Teaching Assistant PhD Student Sonia Luka, Iuliu Hatieganu University of Medicine and PharmacyPrincipal Investigator

Lead Sponsor

Iuliu Hatieganu University of Medicine and PharmacyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ELISA Sepsis Biomarkers dosage	Diagnostic Test	Observational	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Sepsis or septic shock patients admitted to ED

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cluj County Hospital Emergency Department		Cluj-Napoca	Cluj	400006	Romania

Condition Browse Module

MeSH Terms

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D004630	Emergencies
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

ID	Term
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock

Browse Leaves

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Browse Branches

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