Status:
ENROLLING_BY_INVITATION
Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol
Lead Sponsor:
Beckman Coulter, Inc.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Severe Sepsis
Severe Sepsis Without Septic Shock
Eligibility:
All Genders
18-89 years
Brief Summary
This protocol will collect real-world data retrospectively from the electronic health record (EHR) as data obtained from the delivery of routine medical care to develop a machine learning (ML)-based C...
Detailed Description
The purpose of this study is to gather data for the clinical development of the Sepsis Onset Warning System (SOWS) Software as Medical Device (SaMD) product to support a De Novo FDA submission and com...
Eligibility Criteria
Inclusion
- All races, ages and ethnicities
- All patients admitted to the hospital or presenting to the Emergency Department
Exclusion
- Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).
Key Trial Info
Start Date :
February 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40000 Patients enrolled
Trial Details
Trial ID
NCT05304728
Start Date
February 15 2021
End Date
December 31 2026
Last Update
June 21 2024
Active Locations (10)
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1
University of California, Irvine
Irvine, California, United States, 92697
2
Augusta University Medical School
Augusta, Georgia, United States, 30912
3
Indiana University Health
Indianapolis, Indiana, United States, 46202-5200
4
University Health/ Truman Medical Center
Kansas City, Missouri, United States, 64108