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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05095220
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : November 18, 2021
Information provided by (Responsible Party):

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

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Study Type : Observational
Estimated 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 : November 9, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Observational Cohort

Primary Outcome Measures :
  1. NAVOY® Sepsis prediction performance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    The dimensions of the Sepsis-3 diagnosis criteria that the subjects meet during their ICU stay.

  4. Sepsis specific management [ Time Frame: 6 months ]
    Actions taken at the ICU specifically as part of sepsis detection, prevention, or treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult ICU patients admitted to the ICU during the enrolment period.

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.

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): NCT05095220

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Contact: David Becedas, MSc +46-722328348
Contact: Andreas Macura, MSc +46-768668842

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Southern General Hospital Recruiting
Stockholm, Sweden
Contact: Martin Arlbrandt, MD    +46723074417   
Principal Investigator: Martin Arlbrandt, MD         
Principal Investigator: Mattias Günther, MD PhD         
Sponsors and Collaborators
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Principal Investigator: Martin Arlbrandt, MD Southern General Hospital
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Responsible Party: AlgoDx Identifier: NCT05095220    
Other Study ID Numbers: SEP-SE-03
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 AlgoDx:
decision support
machine learning
intensive care
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes