Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol

ClinicalTrials.gov ID: NCT05304728

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Official title

Sepsis Onset Warning System [SOWS] Master Enrollment Study Protocol

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05304728
Recruitment status: Enrolling by invitation
Study type: Observational
Phase: Not listed
Lead sponsor: Beckman Coulter, Inc.; Industry
Enrollment: 40,000 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range: 18 Years to 89 Years
Sex: All
Healthy volunteers: Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Feb 15, 2021 (Actual)
Primary completion: Mar 30, 2025 (Estimated)
Completion: Dec 31, 2026 (Estimated)
Last update posted: Jun 21, 2024

2021 – 2026

United States locations

U.S. sites: 10
U.S. states: 7
U.S. cities: 9

Facility	City	State	ZIP	Site status
University of California, Irvine	Irvine	California	92697	—
Augusta University Medical School	Augusta	Georgia	30912	—
Indiana University Health	Indianapolis	Indiana	46202-5200	—
University Health/ Truman Medical Center	Kansas City	Missouri	64108	—
University of Kansas Medical Center	Kansas City	Missouri	66103	—
Hackensack University Medical Center	Hackensack	New Jersey	07601	—
WakeMed Health	Raleigh	North Carolina	27610	—
University of Cininnati	Cincinnati	Ohio	45221	—
MetroHealth Systems	Cleveland	Ohio	44109	—
The Ohio State University	Columbus	Ohio	43210	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05304728, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 21, 2024 · Synced Nov 14, 2026