Integration of NAVOY® Sepsis in an Electronic Health Record System

Completed

• Conditions: Sepsis

• Registration Number: NCT05095220
• Lead Sponsor: AlgoDx

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-27
• Study Start: 2022-05-27
• Primary Completion: 2023-03-08
• Study Completion: 2023-03-08
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Fulfilment of Sepsis-3 criteria	6 months	The dimensions of the Sepsis-3 diagnosis criteria that the subjects meet during their ICU stay.
Sepsis specific management	6 months	Actions taken at the ICU specifically as part of sepsis detection, prevention, or treatment.

Trial Locations

Locations (1)

Southern General Hospital; 🇸🇪 Stockholm, Sweden