Early Prediction of Sepsis in Hospitalized Patients Using a Machine Learning Algorithm, a Randomized Clinical Validation Trial.

AlgoDx1 site in 1 country320 target enrollmentDecember 1, 2020

ConditionsSepsis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sepsis
Sponsor: AlgoDx
Enrollment: 320
Locations: 1
Primary Endpoint: Validate the prognostic accuracy of the algorithm at predicting sepsis.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this clinical trial a novel Medical Device Software will be validated prospectively. The software incorporates a machine learning algorithm capable of predicting sepsis by using routine clinical variables in adult patients at Intensive Care Units.

Registry

clinicaltrials.gov

Start Date

December 1, 2020

End Date

November 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AlgoDx

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patient (age ≥18 years).
•Patient is admitted to the ICU during the recruitment period of the trial.

Exclusion Criteria

•Patient is participating in another interventional clinical trial which, as judged by the investigator, could potentially impact variables used by the sepsis prediction algorithm or has participated in such interventional clinical trial within the last 30 days.
•Patient is known to be pregnant.
•Death is deemed imminent and inevitable, at the investigator's discretion.
•Patient has, due to chronic reduced mental capacity, been assessed by the investigator as incapable of making an informed decision
•Patient has previously been enrolled in this trial.

Outcomes

Primary Outcomes

Validate the prognostic accuracy of the algorithm at predicting sepsis.

Time Frame: Up to 30 days (ICU hospitalization period)

In order to clinically validate the sepsis prediction performance the following endpoints have been selected: * accuracy, * specificity, and * sensitivity of the AlgoDx Sepsis Prediction Algorithm in the SoC group (not possible to assess these in the SoC + Algorithm cohort).