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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04804306
Other study ID # C01238
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 5, 2021
Est. completion date June 6, 2022

Study information

Verified date July 2022
Source Beckman Coulter, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).


Description:

The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management.


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date June 6, 2022
Est. primary completion date June 6, 2022
Accepts healthy volunteers
Gender All
Age group 19 Years to 89 Years
Eligibility Inclusion Criteria: - Adult (18 to 89 years) - All race and ethnicities - Presenting to the emergency department with suspicion of infection - Whose assessment includes a CBC with differential - Meets EMR Sepsis Definition Exclusion Criteria: - Pregnancy - Prisoners - Transfers from other ED - Previously enrolled

Study Design


Intervention

Device:
Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)
MDW measurement used to detect sepsis. Results will not be used to manage patients.

Locations

Country Name City State
United States Hackensack University Medical Center Hackensack New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Health & Economic Benefits for Hospital Stay - Simulated MDW's ability to reduce length of hospital stay Within 12 hours from presentation to the emergency department
Other Health & Economic Benefits for Intensive Care Unit Stay - Simulated MDW's ability to reduce length of intensive care unit stay Within 12 hours from presentation to the emergency department
Other Health & Economic Benefits for Mortality - Simulated MDW's ability to reduce in-house mortality Within 12 hours from presentation to the emergency department
Primary Potential reduction of Time to Antibiotics MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated Within 12 hours from presentation to the emergency department
Secondary Performance MDW's ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition Within 12 hours from presentation to the emergency department
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