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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Test: CBC-Diff Monocyte Volume Width Distribution | MDW measurement used to detect sepsis as part of the CBC-Diff ordered by ED Physician as part of the Institution's Standard of Care. Results will not be used to manage patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW) | Device | MDW measurement used to detect sepsis. Results will not be used to manage patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Health & Economic Benefits for Intensive Care Unit Stay - Simulated |
Inclusion Criteria:
Exclusion Criteria:
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All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Parrillo, MD | Hackensack Meridian Health | Principal Investigator |
| Keri Bicking, PharmD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004194 | Disease |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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MDW's ability to reduce length of intensive care unit stay
| Within 12 hours from presentation to the emergency department |
| Health & Economic Benefits for Mortality - Simulated | MDW's ability to reduce in-house mortality | Within 12 hours from presentation to the emergency department |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |