Evaluation of Monocyte Volume Distribution Width (MDW) for Early Detection of Sepsis
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 7/15/2018 |
| Start Date: | June 19, 2017 |
| End Date: | January 26, 2018 |
Evaluation of Monocyte Volume Width Distribution (MDW) for Early Detection of Sepsis or Developing Sepsis on the UniCell DxH800 Hematology Analyzer
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.
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.
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.
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
We found this trial at
3
sites
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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