Adult Disease, Emergency Department, Sepsis, Severe Sepsis
Conditions
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).
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.
Interventions
DIAGNOSTIC_TESTCBC-DIFF Monocyte Volume Width Distribution (MDW)
MDW measurement used to detect sepsis. Results will not be used to manage patients.
Sponsors
Beckman Coulter, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Potential reduction of Time to Antibiotics | 12 hrs after ED presentation | Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance | 12 hrs 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
| Measure | Time frame | Description |
|---|---|---|
| Health & Economic Benefits for Time to Antibiotics - Simulated | 12 hrs 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 hrs after ED presentation | Determine MDW's ability to potentially reduced ICU stay, if applicable, using a simulated economic model. |
| Health & Economic Benefits for Mortality - Simulated | 12 hrs after ED presentation | Determine MDW's ability to potentially reduced hospital morality, if applicable, using a simulated economic model. |
Countries
United States
Outcome results
None listed