Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBC-Diff Monocyte Volume Width Distribution | Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Potential reduction of Time to Antibiotics Ordered and Administered | Monocyte Distribution Width's [MDW] ability to reduce time to first antibiotics ordered by physician (decision to treat) and first antibiotics administered via a simulation | Within 12 hours from presentation to the emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| Performance | Monocyte Distribution Width's [MDW] ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve. | Within 12 hours from presentation to the emergency department |
| Measure | Description | Time Frame |
|---|---|---|
| Health & Economic Benefits for Hospital Stay - Simulated | Monocyte Distribution Width's [MDW] ability to reduce length of hospital stay by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve. | Within 12 hours from presentation to the emergency department |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Magdalena Czader, MD | Indiana University Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004194 | Disease |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
| Health & Economic Benefits for Intensive Care Unit Stay - Simulated |
Monocyte Distribution Width's [MDW] ability to reduce length of intensive care unit stay by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve. |
| Within 12 hours from presentation to the emergency department |
| Health & Economic Benefits for Mortality - Simulated | Monocyte Distribution Width's [MDW] ability to reduce in-house mortality by earlier detection of sepsis by using AUC (Area Under The Curve) ROC (Receiver Operating Characteristics) curve. | Within 12 hours from presentation to the emergency department |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |