Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Washington University
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| CBC-Diff Monocyte Volume Width Distribution Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential |
Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)
MDW measurement will be used to detect sepsis. Results will not be used to manage patients.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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 Criteria
Criteria
Inclusion Criteria:
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All race and ethnicities
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Presenting to the emergency department with suspicion of infection
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Whose assessment includes a CBC with differential
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Meets EMR Sepsis Definition
Exclusion Criteria:
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Pregnancy
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Prisoners
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Transfers from other ED
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Previously enrolled
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Beckman Coulter, Inc.
Investigators
- Principal Investigator: Tiffany Osborn, MD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C48392