Sepsis Post Market Clinical Utility Simple Endpoint Study - Indiana University Hospital

Study Overview
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Brief Summary
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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).

Detailed Description
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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

Official Title
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Post Market Clinical Utility of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) - Indiana University Hospital

Conditions
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Sepsis, Adult Disease, Severe Sepsis, Emergency Department

Intervention / Treatment
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* Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CBC-Diff Monocyte Volume Width Distribution<br>Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential | Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)<br>* MDW measurement will be used to detect sepsis. Results will not be used to manage patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |