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OpenTrials
Completed

NCT Number: NCT05095220

Integration of NAVOY® Sepsis in an Electronic Health Record System

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern General Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AlgoDx

Industry

Registry information

Official study title

Integration and Evaluation of a Machine Learning Algorithm for Sepsis Prediction in an Electronic Health Record System - a Prospective Observational Study

Acronym: GENIUS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2021
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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