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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Sham Comparator | Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines. |
|
| Standard of Care + AlgoDx Sepsis Prediction Algorithm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unblinded AlgoDx Sepsis Prediction Algorithm | Device | When applicable, a sepsis prediction alert is displayed in the AlgoDx Medical Device Software. |
|
| 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:
| Up to 30 days (ICU hospitalization period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensiv- och perioperativ vård | Malmö | 20502 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38245375 | Derived | Persson I, Macura A, Becedas D, Sjovall F. Early prediction of sepsis in intensive care patients using the machine learning algorithm NAVOY(R) Sepsis, a prospective randomized clinical validation study. J Crit Care. 2024 Apr;80:154400. doi: 10.1016/j.jcrc.2023.154400. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Blinded AlgoDx Sepsis Prediction Algorithm | Other | Standard of Care, i.e. no sepsis prediction alert. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |