Comparison of Sepsis Prediction Algorithms

NCT05943938 | Not Yet Recruiting

• 2 other identifiers: STUDY000059582024P008316
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 7

Brief Summary

Sepsis is a severe response to infection resulting in organ dysfunction and often leading to death. More than 1.5 million people get sepsis every year in the U.S., and 270,000 Americans die from sepsis annually. Delays in the diagnosis of sepsis lead to increased mortality. Several clinical decision support algorithms exist for the early identification of sepsis. The research team will compare the performance of three sepsis prediction algorithms to identify the algorithm that is most accurate and clinically actionable. The algorithms will run in the background of the electronic health record (EHR) and the predictions will not be revealed to patients or clinical staff. In this current evaluation study, the algorithms will not affect any part of a patient's care. The algorithms will be deployed across the Emory healthcare system on data from all patients presenting to the emergency department.

Conditions

Sepsis

Keywords

Infection; Emergency Department; Algorithm; Prediction

Outcome Measures

Primary Outcomes (1)

• Patient hospitalization-level area under curve (AUC) for identification of sepsis,

  Definition of Sepsis using the Centers for Disease Control and Prevention (CDC) Adult Sepsis Surveillance.

  Duration of hospital stay (until discharge or death), an expected average of 30 days

Secondary Outcomes (7)

• Sensitivity, specificity, and Positive and Negative Predictive Value of algorithms

  Duration of hospital stay (until discharge or death), an expected average of 30 days

• Lead time to antibiotic administration

  Duration of hospital stay (until discharge or death), an expected average of 30 days

• Percent expected increase in unnecessary antibiotics

  Duration of hospital stay (until discharge or death), an expected average of 30 days

• Number needed to screen

  Duration of hospital stay (or death), an expected average of 30 days

• Number of Total and false alert burden

  Duration of hospital stay (until discharge or death), an expected average of 30 days

Study Arms (1)

ED Patients

All adult patients presenting to Emergency Departments (ED) in the Emory Healthcare system

Other: Epic Sepsis Model Version - 1; Other: Epic Sepsis Model Version - 2; Other: Emory Sepsis Model

Interventions

Epic Sepsis Model Version - 1 OTHER

The Epic Sepsis Model (ESM) version 1, a proprietary sepsis prediction model.

Also known as: Proprietary Epic sepsis algorithm -1

ED Patients

Epic Sepsis Model Version - 2 OTHER

The Epic Sepsis Model (ESM) version 2, a proprietary sepsis prediction model.

Also known as: Proprietary Epic sepsis algorithm -2

ED Patients

Emory Sepsis Model OTHER

Emory internal algorithm

Also known as: Emory Sepsis Algorithm

ED Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted through the ED from the time they arrive at the hospital until discharge, death, or initiation of intravenous antibiotics.

You may qualify if:

• All adult patients admitted through the ED

You may not qualify if:

• None

Sponsors & Collaborators

• Emory University: lead

Study Sites (7)

Emory Midtown Hospital

Atlanta, Georgia, 30308, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30308, United States

Location

Emory Healthcare System

Atlanta, Georgia, 30322, United States

Location

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

Location

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097, United States

Location

Emory Hillandale Hospital

Lithonia, Georgia, 30058, United States

Location

MeSH Terms

Conditions

Sepsis; Infections; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Sivasubramanium Bhavani, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sivasubramanium Bhavani, MD

CONTACT

404-712-2970; sivasubramanium.bhavani@emory.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared beginning 6 months after publication, without a specified end date.
• Access Criteria: To gain access, data requestors will need to sign a data access agreement.

Locations

US (7)