Clinical trial NCT05304728: Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol
Official title: Sepsis Onset Warning System [SOWS] Master Enrollment Study Protocol
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Severe Sepsis
Severe Sepsis Without Septic Shock
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2022-03-31
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This protocol has open enrollment to all genders, ages, and health statuses in patients admitted to the hospital or presenting to the ED.

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 Clinical Decision Support (CDS) system for severe sepsis prediction and detection.

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 commercialization in the United States. Product development of SOWS is funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.

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.

Eligibility criteria: Inclusion Criteria:

* All races, ages and ethnicities
* All patients admitted to the hospital or presenting to the Emergency Department

Exclusion Criteria:

* Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).

Primary outcomes:
measure: Severe Sepsis
timeFrame: Within 6 hours from presentation to the emergency department
Secondary outcomes:
measure: Mortality
timeFrame: Within 6hours from presentation to the emergency department
measure: Length of Stay
timeFrame: Within 6hours from presentation to the emergency department
measure: Re-admission Rates
timeFrame: Within 6hours from presentation to the emergency department
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Augusta
country: United States
facility: Augusta University Medical School
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Kansas City
country: United States
facility: University Health/ Truman Medical Center
state: Missouri
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Raleigh
country: United States
facility: WakeMed Health
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cininnati
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Systems
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Elliott Crouser, MD
role: PRINCIPAL_INVESTIGATOR
References: