Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Severe Sepsis, Severe Sepsis Without Septic Shock. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sepsis Onset Warning System [SOWS] Master Enrollment Study Protocol
Overview
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.
Primary outcome measures
- Severe Sepsis [Time frame: Within 6 hours from presentation to the emergency department]
Secondary outcome measures (3)
- Mortality [Time frame: Within 6hours from presentation to the emergency department]
- Length of Stay [Time frame: Within 6hours from presentation to the emergency department]
- Re-admission Rates [Time frame: Within 6hours from presentation to the emergency department]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 10 centers
- University of California, Irvine — Irvine
- Augusta University Medical School — Augusta
- Indiana University Health — Indianapolis
- University Health/ Truman Medical Center — Kansas City
- University of Kansas Medical Center — Kansas City
- Hackensack University Medical Center — Hackensack
- WakeMed Health — Raleigh
- University of Cininnati — Cincinnati
- … and 2 more centers
Identifiers
NCT: NCT05304728 · 2.7.2-1