Early Prediction of Sepsis

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Device: Unblinded AlgoDx Sepsis Prediction Algorithm
* Other: Blinded AlgoDx Sepsis Prediction Algorithm


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard of Care<br>Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines. | Other: Blinded AlgoDx Sepsis Prediction Algorithm<br>* Standard of Care, i.e. no sepsis prediction alert.<br>|
| Experimental: Standard of Care + AlgoDx Sepsis Prediction Algorithm<br>Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines, and sepsis prediction algorithm alerts are unblinded to clinical staff. | Device: Unblinded AlgoDx Sepsis Prediction Algorithm<br>* When applicable, a sepsis prediction alert is displayed in the AlgoDx Medical Device Software.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the prognostic accuracy of the algorithm at predicting sepsis. | 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). | Up to 30 days (ICU hospitalization period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediction