Sepsis, Severe Infection
Conditions
Brief summary
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.
Detailed description
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.
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
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults (18-89 years) presenting to ED * All races & ethnicities * CBC with Differential performed upon presentation * Subjects with at least 12 hours of follow-up in ED (or in-patient if admitted)
Exclusion criteria
* Previously enrolled * Subjects discharged \<12 hours form ED presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2) | 12 hours after presentation to the ED | Determination of the diagnostic accuracy, area under the receiver operating characteristic curve |
Countries
United States
Outcome results
None listed