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.|
|ClinicalTrials.gov Identifier: NCT05095220|
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : November 18, 2021
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
- 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.
- 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.
- 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.
- 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.
- Sepsis specific management [ Time Frame: 6 months ]Actions taken at the ICU specifically as part of sepsis detection, prevention, or treatment.
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 ClinicalTrials.gov identifier (NCT number): NCT05095220
|Contact: David Becedas, MScfirstname.lastname@example.org|
|Contact: Andreas Macura, MScemail@example.com|
|Southern General Hospital||Recruiting|
|Contact: Martin Arlbrandt, MD +46723074417 firstname.lastname@example.org|
|Principal Investigator: Martin Arlbrandt, MD|
|Principal Investigator: Mattias Günther, MD PhD|
|Principal Investigator:||Martin Arlbrandt, MD||Southern General Hospital|