Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC

Sepsis Clinical Trial

Official title:

Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Hackensack University Medical Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804306
• Other study ID #: C01238
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Adult Disease
• Emergencies
• Emergency Department
• Sepsis
• Severe Sepsis
• Toxemia

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