Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
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 |
|---|---|---|
|
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 |
|---|---|
| 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 |
Device: Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)
MDW measurement used to detect sepsis. Results will not be used to manage patients.
|
Outcome Measures
Primary Outcome Measures
- Potential reduction of Time to Antibiotics [Within 12 hours from presentation to the emergency department]
MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated
Secondary Outcome Measures
- Performance [Within 12 hours from presentation to the emergency department]
MDW's ability to identify Sepsis vs Non-Sepsis when using a Sepsis electronic medical record definition
Other Outcome Measures
- Health & Economic Benefits for Hospital Stay - Simulated [Within 12 hours from presentation to the emergency department]
MDW's ability to reduce length of hospital stay
- Health & Economic Benefits for Intensive Care Unit Stay - Simulated [Within 12 hours from presentation to the emergency department]
MDW's ability to reduce length of intensive care unit stay
- Health & Economic Benefits for Mortality - Simulated [Within 12 hours from presentation to the emergency department]
MDW's ability to reduce in-house mortality
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
Sponsors and Collaborators
- Beckman Coulter, Inc.
Investigators
- Principal Investigator: Joseph Parrillo, MD, Hackensack Meridian Health
- Principal Investigator: Keri Bicking, PharmD, Hackensack Meridian Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C01238