Effect of a Sepsis Prediction Algorithm on Clinical Outcomes

NCT ID: NCT03960203

Last Updated: 2019-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-06-30

Brief Summary

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In this clinical outcomes analysis, the effect of a machine learning algorithm for severe sepsis prediction on in-hospital mortality, hospital length of stay, and 30-day readmission was evaluated.

Detailed Description

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Materials and Methods: Clinical outcomes evaluation performed on a multiyear, multicenter clinical data set of real-world data containing 75,147 patient encounters from nine hospitals. Mortality, hospital length of stay, and 30-day readmission analysis performed for 17,758 adult patients who met two or more Systemic Inflammatory Response Syndrome (SIRS) criteria at any point during their stay.

Conditions

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Severe Sepsis

Study Design

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Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Comparator

The comparator arm will involve patients monitored by InSight.

Group Type EXPERIMENTAL

InSight

Intervention Type DIAGNOSTIC_TEST

Clinical decision support (CDS) system for severe sepsis detection and prediction

Interventions

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InSight

Clinical decision support (CDS) system for severe sepsis detection and prediction

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* All patients over the age of 18 presenting to the emergency department or admitted to an inpatient unit at the participating facilities were automatically included for clinical outcomes analysis

Exclusion Criteria

* Patients under the age of 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dascena

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ritankar Das, MSc

Role: PRINCIPAL_INVESTIGATOR

Dascena

References

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Burdick H, Pino E, Gabel-Comeau D, McCoy A, Gu C, Roberts J, Le S, Slote J, Pellegrini E, Green-Saxena A, Hoffman J, Das R. Effect of a sepsis prediction algorithm on patient mortality, length of stay and readmission: a prospective multicentre clinical outcomes evaluation of real-world patient data from US hospitals. BMJ Health Care Inform. 2020 Apr;27(1):e100109. doi: 10.1136/bmjhci-2019-100109.

Reference Type DERIVED
PMID: 32354696 (View on PubMed)

Other Identifiers

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05172019

Identifier Type: -

Identifier Source: org_study_id

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