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GENIUS: Integration of NAVOY® Sepsis in an Electronic Health Record System

Sponsor
AlgoDx (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05095220
Collaborator
(none)
1,000
Enrollment
1
Location
12.7
Anticipated Duration (Months)
78.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Integration and Evaluation of a Machine Learning Algorithm for Sepsis Prediction in an Electronic Health Record System - a Prospective Observational Study
    Actual Study Start Date :
    Nov 9, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Observational Cohort

    Outcome Measures

    Primary Outcome Measures

    1. NAVOY® Sepsis prediction performance [6 months]

      NAVOY® Sepsis prediction output within the simulated environment will be monitored and compared to the observed fulfilment of Sepsis-3 diagnosis criteria and sepsis specific management.

    Secondary Outcome Measures

    1. Integration validation [6 months]

      A technical checklist will be used in order to validate the integration between NAVOY® Sepsis and the electronic health record system.

    2. NAVOY® Sepsis prediction results [6 months]

      The NAVOY® Sepsis predictions results indicate if the subject is at risk of developing sepsis within the coming hours. The results are not made available to ICU staff.

    3. Fulfilment of Sepsis-3 criteria [6 months]

      The dimensions of the Sepsis-3 diagnosis criteria that the subjects meet during their ICU stay.

    4. Sepsis specific management [6 months]

      Actions taken at the ICU specifically as part of sepsis detection, prevention, or treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The subject is admitted to the ICU during the enrolment period.

    • The subject is 18 years of age or older at the time of admission to the ICU.

    Exclusion Criteria:
    • None.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southern General Hospital Stockholm Sweden

    Sponsors and Collaborators

    • AlgoDx

    Investigators

    • Principal Investigator: Martin Arlbrandt, MD, Southern General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AlgoDx
    ClinicalTrials.gov Identifier:
    NCT05095220
    Other Study ID Numbers:
    • SEP-SE-03
    First Posted:
    Oct 27, 2021
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AlgoDx
    sepsis
    ICU
    prediction
    decision support
    machine learning
    intensive care
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Jul 26, 2022