Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol
NCT ID: NCT05304728
Last Updated: 2024-06-21
Study Results
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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ENROLLING_BY_INVITATION
40000 participants
OBSERVATIONAL
2021-02-15
2026-12-31
Brief Summary
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Detailed Description
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Data will be obtained from passive prospective collection of patient encounter data throughout the duration of the planned study to support the product development life cycle activities associated with developing the Sepsis Onset Warning System (SOWS) for severe sepsis risk detection. Inputs from patient health records in combination with proprietary hematology parameters developed by Beckman Coulter, such as Monocyte Distribution Width (MDW), will be used. The SOWS tool will look to use clinical measurements which are commonly and reliably available in the EHR as structured data elements, such as heart rate, temperature, blood pressure, and laboratory results and account for changes in these values over time.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Primary Objective: Severe Sepsis
The primary endpoint for this study is defined as the presence of sufficient data for SOWS training and algorithm development to proceed with subsequent validation. To provide sufficient data subsets (severe sepsis EHR encounters) for training and validation of the Sepsis Onset Warning System algorithm. There will not be any interventions administered.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* All patients admitted to the hospital or presenting to the Emergency Department
Exclusion Criteria
18 Years
89 Years
ALL
No
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Beckman Coulter, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Elliott Crouser, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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University of California, Irvine
Irvine, California, United States
Augusta University Medical School
Augusta, Georgia, United States
Indiana University Health
Indianapolis, Indiana, United States
University Health/ Truman Medical Center
Kansas City, Missouri, United States
University of Kansas Medical Center
Kansas City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
WakeMed Health
Raleigh, North Carolina, United States
University of Cininnati
Cincinnati, Ohio, United States
MetroHealth Systems
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Countries
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Other Identifiers
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2.7.2-1
Identifier Type: -
Identifier Source: org_study_id
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