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The measurement of monocyte volume width distribution (MDW) is intended for use with adult patients presenting to the emergency department (ED), where a CBC with Differential has been ordered, as an aid in the early detection of patients with or developing sepsis. The study will establish the clinical performance of MDW for detection of sepsis in the ED.
A prospective multi-center study to establish the clinical utility of the measurement of monocyte volume width distribution, a cell population parameter of the CBC-Differential, on the Beckman Coulter Unicel DxH analyzers. The study will validate the cut-off for the early detection of sepsis in an adult emergency room population where the standard of care included a CBC with Differential and will evaluate the diagnostic performance of the parameter.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBC-Diff Monocyte volume width distribution (MDW) | Diagnostic Test | MDW measurement used to detect sepsis. Results will not be used to manage patients |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2) | Determination of the diagnostic accuracy, area under the receiver operating characteristic curve | 12 hours after presentation to the ED |
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Inclusion Criteria:
Exclusion Criteria:
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All adult patients with suspicion who present to ED and for whom CBC with Diff is performed upon ED presentation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States | ||
| The Ohio State University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32391157 | Derived | Crouser ED, Parrillo JE, Martin GS, Huang DT, Hausfater P, Grigorov I, Careaga D, Osborn T, Hasan M, Tejidor L. Monocyte distribution width enhances early sepsis detection in the emergency department beyond SIRS and qSOFA. J Intensive Care. 2020 May 5;8:33. doi: 10.1186/s40560-020-00446-3. eCollection 2020. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Columbus |
| Ohio |
| 43210 |
| United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |