An observational study in Sepsis, Adult Disease and Severe Sepsis, sponsored by Beckman Coulter, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Beckman Coulter, Inc. · Observational
The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).
The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 1,139 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Beckman Coulter, Inc. is the lead sponsor of 31 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
Exclusion Criteria:
Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential
Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)
MDW measurement will be used to detect sepsis. Results will not be used to manage patients.
Potential reduction of Time to Antibiotics
Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated
Time frame: 12 hours after ED presentation
Performance
Validate MDW's ability to identify incidence of patients diagnosed as Sepsis vs Non-Sepsis, including SIRS and milder forms of infection (non-SIRS) meeting Sepsis EMR definition of \>=2 SIRS criteria within 12 hours of ED presentation and any microbial testing collected within 24 hours of triage in the ED
Time frame: 12 hours after ED presentation
Health & Economic Benefits for Time to Antibiotics - Simulated
Determine MDW's ability to potentially reduced hospital stay using a simulated economic model
Time frame: 12 hours after ED presentation
Health & Economic Benefits for Hospital Stay - Simulated
Determine MDW's ability to potentially reduced Hospital stay, if applicable, using a simulated economic model
Time frame: 12 hours after ED presentation
Health & Economic Benefits for Mortality - Simulated
Determine MDW's ability to potentially reduced hospital morality, if applicable, using a simulated economic model
Time frame: 12 hours after ED presentation
Health & Economic Benefits for ICU Stay - Simulated
Determine MDW's ability to potentially reduced ICU stay, if applicable, using a simulated economic model
Time frame: 12 hours after ED presentation
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Beckman Coulter, Inc.