Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol

NCT05304728 | Enrolling By Invitation

• 1 other identifier: 2.7.2-1
• Study Type: observational
• Target: 40,000
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Severe Sepsis; Severe Sepsis Without Septic Shock

Outcome Measures

Primary Outcomes (1)

• Severe Sepsis

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

  Within 6 hours from presentation to the emergency department

Secondary Outcomes (3)

• Mortality

  Within 6hours from presentation to the emergency department

• Length of Stay

  Within 6hours from presentation to the emergency department

• Re-admission Rates

  Within 6hours from presentation to the emergency department

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

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).

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (10)

University of California, Irvine

Irvine, California, 92697, United States

Location

Augusta University Medical School

Augusta, Georgia, 30912, United States

Location

Indiana University Health

Indianapolis, Indiana, 46202-5200, United States

Location

University Health/ Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

University of Kansas Medical Center

Kansas City, Missouri, 66103, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

WakeMed Health

Raleigh, North Carolina, 27610, United States

Location

University of Cininnati

Cincinnati, Ohio, 45221, United States

Location

MetroHealth Systems

Cleveland, Ohio, 44109, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elliott Crouser, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: March 31, 2022
• Study Start: February 15, 2021
• Primary Completion: March 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)