Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol

NCT05304728 · tracked via the Priya Life Science USA tracker

Sponsor

Beckman Coulter, Inc.

Phase

Observational

Started

2021-02-15

Last updated

2024-06-21

Condition(s) studied

Severe SepsisSevere Sepsis Without Septic Shock

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

89 Years

Healthy volunteers

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).

Primary outcome measure(s)

Severe Sepsis — Within 6 hours from presentation to the emergency department
Identify patients having Severe Sepsis with the use of electronic health data

Trial sites (10)

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05304728 on ClinicalTrials.gov ↗ ← All trials in the USA