Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Washington University
Post Market Observational Study of ESId (MDW Hematology Parameter) for Early Sepsis Detection in the Emergency Department (US Hospitals) and Potential Reduction in Time to Antibiotics - Washington University
1 other identifier
observational
1,139
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2020
CompletedFirst Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2020
CompletedMarch 17, 2021
July 1, 2020
6 months
April 16, 2020
March 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Potential reduction of Time to Antibiotics
Validate MDW's ability to reduce time to first antibiotics ordered by physician (decision to treat)-Simulated
12 hours after ED presentation
Secondary Outcomes (1)
Performance
12 hours after ED presentation
Other Outcomes (4)
Health & Economic Benefits for Time to Antibiotics - Simulated
12 hours after ED presentation
Health & Economic Benefits for Hospital Stay - Simulated
12 hours after ED presentation
Health & Economic Benefits for Mortality - Simulated
12 hours after ED presentation
- +1 more other outcomes
Study Arms (1)
CBC-Diff Monocyte Volume Width Distribution
Monocyte Volume Width Distribution (MDW) is part of the CBC with Differential
Interventions
MDW measurement will be used to detect sepsis. Results will not be used to manage patients.
Eligibility Criteria
All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of care
You may qualify if:
- All race and ethnicities
- Presenting to the emergency department with suspicion of infection
- Whose assessment includes a CBC with differential
- Meets EMR Sepsis Definition
You may not qualify if:
- Pregnancy
- Prisoners
- Transfers from other ED
- Previously enrolled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiffany Osborn, MD
Washington University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
April 20, 2020
Study Start
February 3, 2020
Primary Completion
July 17, 2020
Study Completion
July 17, 2020
Last Updated
March 17, 2021
Record last verified: 2020-07