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Early Prediction of Sepsis (ExPRESS)

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ClinicalTrials.gov Identifier: NCT04570618
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : December 7, 2020
Sponsor:
Information provided by (Responsible Party):
AlgoDx

Tracking Information
First Submitted Date  ICMJE September 22, 2020
First Posted Date  ICMJE September 30, 2020
Last Update Posted Date December 7, 2020
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2020)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
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 ExPRESS algorithm in the SoC group (not possible to assess these in the SoC + Algorithm cohort).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Prediction of Sepsis
Official Title  ICMJE Early Prediction of Sepsis in Hospitalized Patients Using a Machine Learning Algorithm, a Randomized Clinical Validation Trial.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Sepsis
Intervention  ICMJE
  • Device: Unblinded AlgoDx Sepsis Prediction Algorithm
    When applicable, a sepsis prediction alert is displayed in the AlgoDx Medical Device Software.
  • Other: Blinded AlgoDx Sepsis Prediction Algorithm
    Standard of Care, i.e. no sepsis prediction alert.
Study Arms  ICMJE
  • Sham Comparator: Standard of Care
    Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines.
    Intervention: Other: Blinded AlgoDx Sepsis Prediction Algorithm
  • Experimental: Standard of Care + AlgoDx Sepsis Prediction Algorithm
    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: Device: Unblinded AlgoDx Sepsis Prediction Algorithm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 25, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2021
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Patient is known to be pregnant.
  3. Death is deemed imminent and inevitable, at the investigator's discretion.
  4. Patient has, due to chronic reduced mental capacity, been assessed by the investigator as incapable of making an informed decision
  5. Patient has previously been enrolled in this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04570618
Other Study ID Numbers  ICMJE SEP-SE-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AlgoDx
Study Sponsor  ICMJE AlgoDx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AlgoDx
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP