Back to resultsEarly Prediction of Sepsis (ExPRESS)
Primary Purpose
Sepsis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Unblinded AlgoDx Sepsis Prediction Algorithm
Blinded AlgoDx Sepsis Prediction Algorithm
Sponsored by
About this trial
This is an interventional diagnostic trial for Sepsis focused on measuring Prediction
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.
Sites / Locations
- Intensiv- och perioperativ vård
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Standard of Care
Standard of Care + AlgoDx Sepsis Prediction Algorithm
Arm Description
Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04570618
Brief Title
Early Prediction of Sepsis
Acronym
ExPRESS
Official Title
Early Prediction of Sepsis in Hospitalized Patients Using a Machine Learning Algorithm, a Randomized Clinical Validation Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlgoDx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Prediction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
Sham Comparator
Arm Description
Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines.
Arm Title
Standard of Care + AlgoDx Sepsis Prediction Algorithm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Unblinded AlgoDx Sepsis Prediction Algorithm
Intervention Description
When applicable, a sepsis prediction alert is displayed in the AlgoDx Medical Device Software.
Intervention Type
Other
Intervention Name(s)
Blinded AlgoDx Sepsis Prediction Algorithm
Intervention Description
Standard of Care, i.e. no sepsis prediction alert.
Primary Outcome Measure Information:
Title
Validate the prognostic accuracy of the algorithm at predicting sepsis.
Description
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).
Time Frame
Up to 30 days (ICU hospitalization period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Intensiv- och perioperativ vård
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Prediction of Sepsis
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