Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Washington University

NCT04353388 — Completed, 1139 participants, Beckman Coulter, Inc.

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Post Market Observational Study of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) and Potential Reduction in Time to Antibiotics - Washington University

Registry	NCT04353388
Status	Completed
Study type	Observational
Enrollment	1139 (Actual)
Sponsor	Beckman Coulter, Inc. (Industry)
Conditions	Sepsis, Adult Disease, Severe Sepsis, Emergency Department
Interventions	CBC-DIFF Monocyte Volume Width Distribution (MDW) (Diagnostic test)
Dates	start 2020-02-03, primary completion 2020-07-17, completion 2020-07-17, first posted 2020-04-20, last updated 2021-03-17
Locations	1 site in United States

-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).

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+Detailed 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

+Arms and interventions

Arm	Type	Interventions	Description
CBC-Diff Monocyte Volume Width Distribution		Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)	Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential

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

+Outcome measures

Primary outcomes

Potential reduction of Time to Antibiotics [12 hours after ED presentation]: Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated

Secondary outcomes

Performance [12 hours after ED presentation]: Validate MDW's ability to identify incidence of patients diagnosed as Sepsis vs Non-Sepsis, including SIRS and milder forms of infection (non-SIRS) meeting Sepsis EMR definition of >=2 SIRS criteria within 12 hours of ED presentation and any microbial testing collected within 24 hours of triage in the ED

Other outcomes

Health & Economic Benefits for Time to Antibiotics - Simulated [12 hours after ED presentation]: Determine MDW's ability to potentially reduced hospital stay using a simulated economic model
Health & Economic Benefits for Hospital Stay - Simulated [12 hours after ED presentation]: Determine MDW's ability to potentially reduced Hospital stay, if applicable, using a simulated economic model
Health & Economic Benefits for Mortality - Simulated [12 hours after ED presentation]: Determine MDW's ability to potentially reduced hospital morality, if applicable, using a simulated economic model
Health & Economic Benefits for ICU Stay - Simulated [12 hours after ED presentation]: Determine MDW's ability to potentially reduced ICU stay, if applicable, using a simulated economic model

+Eligibility

Sex: All, ages: 18 Years to 89 Years

Inclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Washington University	St Louis, Missouri	United States

+Investigators

Tiffany Osborn, MD, Principal investigator, Washington University School of Medicine