Integration of NAVOY® Sepsis in an Electronic Health Record System

Sepsis Clinical Trial

— GENIUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095220
• Other study ID #: SEP-SE-03
• Status: Completed
• Start date: May 27, 2022
• Est. completion date: March 8, 2023

Study information

• Verified date: May 2023
• Source: AlgoDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 8, 2023
• Est. primary completion date: March 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
Sweden	Southern General Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AlgoDx

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NAVOY® Sepsis prediction performance	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.	6 months
Secondary	Integration validation	A technical checklist will be used in order to validate the integration between NAVOY® Sepsis and the electronic health record system.	6 months
Secondary	NAVOY® Sepsis prediction results	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.	6 months
Secondary	Fulfilment of Sepsis-3 criteria	The dimensions of the Sepsis-3 diagnosis criteria that the subjects meet during their ICU stay.	6 months
Secondary	Sepsis specific management	Actions taken at the ICU specifically as part of sepsis detection, prevention, or treatment.	6 months