Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol

Enrolling by invitation

Conditions studied: Severe Sepsis, Severe Sepsis Without Septic Shock

In brief

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.

Key facts

Study ID

NCT05304728

Run by

Beckman Coulter, Inc.

People needed

40000

Starts

2021-02-15

Expected to finish

2026-12-31

Last updated by the study team

2024-06-21

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• University of California, Irvine — Irvine, California, United States
• Augusta University Medical School — Augusta, Georgia, United States
• Indiana University Health — Indianapolis, Indiana, United States
• University Health/ Truman Medical Center — Kansas City, Missouri, United States
• University of Kansas Medical Center — Kansas City, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• WakeMed Health — Raleigh, North Carolina, United States
• University of Cininnati — Cincinnati, Ohio, United States
• MetroHealth Systems — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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