NCT03145428

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

Evaluation of Monocyte Volume Width Distribution (MDW) for Early Detection of Sepsis or Developing Sepsis on the UniCell DxH800 Hematology Analyzer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sepsis
• Severe Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CBC-Diff Monocyte volume width distribution (MDW)	MDW measurement used to detect sepsis. Results will not be used to manage patients

Timeline

• Start date: 2017-06-19
• Primary completion: 2017-12-22
• Completion: 2018-01-26
• First posted: 2017-05-09
• Last updated: 2019-11-22

Locations

3 sites across 1 country: United States