Severe SepsisNCT05304728
Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol
An observational study of Severe Sepsis and Severe Sepsis Without Septic Shock, run by Beckman Coulter, Inc. at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Severe Sepsis, Severe Sepsis Without Septic Shock
- How many people
- 40,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Feb 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- All races, ages and ethnicities
- All patients admitted to the hospital or presenting to the Emergency Department
Who cannot join
- Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Augusta University Medical School
Augusta, Georgia, 30912
University of Cininnati
Cincinnati, Ohio, 45221
MetroHealth Systems
Cleveland, Ohio, 44109
The Ohio State University
Columbus, Ohio, 43210
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University Health
Indianapolis, Indiana, 46202-5200
University of California, Irvine
Irvine, California, 92697
University Health/ Truman Medical Center
Kansas City, Missouri, 64108
University of Kansas Medical Center
Kansas City, Missouri, 66103
WakeMed Health
Raleigh, North Carolina, 27610
About this study
Official title: Sepsis Onset Warning System [SOWS] 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.
Read the 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.
- Conditions
- Severe Sepsis, Severe Sepsis Without Septic Shock
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe Sepsis
Identify patients having Severe Sepsis with the use of electronic health data
Measured: Within 6 hours from presentation to the emergency department
Secondary outcomes (3)
Mortality
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
Measured: Within 6hours from presentation to the emergency department
Length of Stay
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
Measured: Within 6hours from presentation to the emergency department
Re-admission Rates
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
Measured: Within 6hours from presentation to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Feb 2021
- Primary completion30 Mar 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beckman Coulter, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Elliott Crouser, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304728
- Sponsor's protocol ID
- 2.7.2-1
- Status last verified
- Jun 2024
- First submitted
- 23 Mar 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data elements will be retrospectively extracted from electronic health records from the respective sites and fed into the algorithm for performance testing. These data elements will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis Onset Warning System [SOWS] Master Enrollment Study Protocol
- ClinicalTrials.gov ID
- NCT05304728
- Acronym / sponsor ID
- 2.7.2-1
- Conditions
- Severe Sepsis, Severe Sepsis Without Septic Shock
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Beckman Coulter, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- All races, ages and ethnicities
- All patients admitted to the hospital or presenting to the Emergency Department
Key exclusion criteria (1 listed)
- Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No. Data elements will be retrospectively extracted from electronic health records from the respective sites and fed into the algorithm for performance testing. These data elements will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elliott Crouser, MD principal investigator
Ohio State University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Severe Sepsis Without Septic Shock, run by Beckman Coulter, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Sepsis (time frame: Within 6 hours from presentation to the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.