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Effect of a Sepsis Prediction Algorithm on Clinical Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03960203
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Diagnostic Test: InSight Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75147 participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of a Sepsis Prediction Algorithm on Patient Mortality, Length of Stay, and Readmission
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: 1 year ]
    Rate of in-hospital mortality based on SIRS criteria

Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 1 year ]
    Duration of hospital length of stay in days based on SIRS criteria

  2. 30-day readmissions [ Time Frame: 1 year ]
    Rate of patient readmissions within 30 days

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03960203

Sponsors and Collaborators
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Principal Investigator: Ritankar Das, MSc Dascena
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dascena Identifier: NCT03960203    
Other Study ID Numbers: 05172019
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dascena:
Patient mortality
Length of stay
Clinical outcomes
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes