Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-19

Study Completion Date

2018-01-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis Severe Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CBC-Diff Monocyte volume width distribution (MDW)

MDW measurement used to detect sepsis. Results will not be used to manage patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)