Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05304728

Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Severe Sepsis Without Septic Shock Systemic Inflammatory Response Syndrome

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine, Irvine, California, United States

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Severe Sepsis

    Time frame: Within 6 hours from presentation to the emergency department

    Identify patients having Severe Sepsis with the use of electronic health data

Secondary outcomes

  1. Mortality

    Time frame: Within 6hours from presentation to the emergency department

    Hospital mortality at hospital for Severe Sepsis patients identified by algorithm using electronic health data as potential benefits for increased early detection of risk of severe sepsis

  2. Length of Stay

    Time frame: Within 6hours from presentation to the emergency department

    Determine length of stay at hospital for Severe Sepsis patients identified by algorithm using electronic health data as potential benefits for increased early detection of risk of severe sepsis

  3. Re-admission Rates

    Time frame: Within 6hours from presentation to the emergency department

    Determine potential reduction of hospital readmission rates for Severe Sepsis patients identified by algorithm using electronic health data as potential benefits for increased early detection of risk of severe sepsis

Sponsors and collaborators

Lead sponsor

Beckman Coulter, Inc.

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study title

Sepsis Onset Warning System [SOWS] Master Enrollment Study Protocol

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 31, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.