Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol

Conditions

• Severe Sepsis
• Severe Sepsis Without Septic Shock

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Study Details

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 Dates

Start date

Feb 15, 2021

Status verified

Jun 2024

Primary completion

Mar 30, 2025

Completion

Dec 31, 2026

Study Design

Enrollment

40,000 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Severe Sepsis [ Time Frame: Within 6 hours from presentation to the emergency department ]

Locations (10)

Find similar trials in Irvine, CA

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