NCT03960203

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75,147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

May 17, 2019

Last Update Submit

May 22, 2019

Conditions

Severe Sepsis

Keywords

DascenaPatient mortalityLength of stayReadmissionsAlgorithmDiagnosticClinical outcomes

Outcome Measures

Primary Outcomes (1)

  • In-hospital mortality

    Rate of in-hospital mortality based on SIRS criteria

    1 year

Secondary Outcomes (2)

  • Hospital length of stay

    1 year

  • 30-day readmissions

    1 year

Study Arms (1)

Comparator

EXPERIMENTAL

The comparator arm will involve patients monitored by InSight.

Diagnostic Test: InSight

Interventions

InSightDIAGNOSTIC_TEST

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

Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32354696DERIVED

MeSH Terms

Conditions

SepsisDisease

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ritankar Das, MSc

    Dascena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 22, 2019

Study Start

January 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 24, 2019

Record last verified: 2019-05