Possible Roles of MDW in Infection Management in Emergenc... | NCT04448548

Studies
Possible Roles of MDW in Infection Management in Emergency Care

NCT04448548

Sponsor

Szeged University

Status

Completed

Last Update Posted

Jun 26, 2020Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Infection
Sepsis

Interventions

blood sample taking

Countries

Hungary

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 2020

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

Sep 1, 2019Actual

Primary Completion Date

Jan 31, 2020Actual

Completion Date

Jan 31, 2020Actual

First Submitted Date

Jun 24, 2020

First Submission Date that Met QC Criteria

Jun 24, 2020

First Posted Date

Jun 26, 2020Actual

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 24, 2020

Last Update Posted Date

Jun 26, 2020Actual

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

A retrospective study to determine the potential value of MDW among other biomarkers in the diagnosis of infection.

Detailed Description

MDW as a novel indicator can be useful in clinical practice in the emergency care. However, until now, no study has been published about MDW's general relationship and coherence with multiple, conventional laboratory tests for infections, such as PCT, C-reactive protein (CRP), WBC, neutrophil count (NC), neutrophil percentage and immature granulocyte count (IGC) together.

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

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample taking	Other	For study purposes, blood sample was taken during the first medical examination from patients with suspected infection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MDW cutoff value for infection	Cutoff value for MDW indicating infection	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult (18+ years), receiving care for suspected infection

Exclusion Criteria:

refuses to sign the consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult (18+ years), receiving care for suspected infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Szeged, Emergency Department		Szeged			Hungary

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D018805	Sepsis

Ancestor Terms

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided