An Algorithm Driven Sepsis Prediction Biomarker

Not Applicable

Completed

• Conditions: Sepsis; Severe Sepsis; Septic Shock
• Interventions: Other: Severe Sepsis Prediction; Other: Severe Sepsis Detection

• Registration Number: NCT03015454
• Lead Sponsor: Dascena

Brief Summary

A sepsis early warning predictive algorithm, InSight, has been developed and validated on a large, diverse patient cohort. In this prospective study, the ability of InSight to predict severe sepsis patients is investigated. Specifically, InSight is compared with a well established severe sepsis detector in the UCSF electronic health record (EHR).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-31
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-10
• Primary Completion: 2017-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• All adult patients admitted to the participating units will be eligible.

Exclusion Criteria

• All patients younger than 18 years of age will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
With InSight	Severe Sepsis Prediction	Healthcare provider receives an alert from InSight for patients trending towards severe sepsis. Healthcare provider also receives information from the severe sepsis detector in the UCSF electronic health record.
Without InSight	Severe Sepsis Detection	Healthcare provider does not receive any alerts from InSight. Healthcare provider receives information from the severe sepsis detector in the UCSF electronic health record.
With InSight	Severe Sepsis Detection	Healthcare provider receives an alert from InSight for patients trending towards severe sepsis. Healthcare provider also receives information from the severe sepsis detector in the UCSF electronic health record.

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	Through study completion, an average of 45 days

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality	Through study completion, an average of 45 days

Trial Locations

Locations (1)

UCSF Moffit-Long Hospital; 🇺🇸 San Francisco, California, United States