Early Prediction of Sepsis
Not Applicable
Completed
- Conditions
- Sepsis
- Registration Number
- NCT04570618
- Lead Sponsor
- AlgoDx
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Validate the prognostic accuracy of the algorithm at predicting sepsis. 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Intensiv- och perioperativ vård
🇸🇪Malmö, Sweden
Intensiv- och perioperativ vård🇸🇪Malmö, Sweden