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.
Study Type
OBSERVATIONAL
Enrollment
3,000
MDW measurement used to detect sepsis. Results will not be used to manage patients
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Ohio State University
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
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
Time frame: 12 hours after presentation to the ED
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