Effect of a Sepsis Prediction Algorithm on Clinical Outcomes

May 22, 2019 updated by: Dascena

Effect of a Sepsis Prediction Algorithm on Patient Mortality, Length of Stay, and Readmission

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

75147

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comparator
The comparator arm will involve patients monitored by InSight.
Diagnostic test: InSight
Clinical decision support (CDS) system for severe sepsis detection and prediction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: 1 year
Rate of in-hospital mortality based on SIRS criteria
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: 1 year
Duration of hospital length of stay in days based on SIRS criteria
1 year
30-day readmissions
Time Frame: 1 year
Rate of patient readmissions within 30 days
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dascena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 17, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05172019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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