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Effect of a Sepsis Prediction Algorithm on Clinical Outcomes

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ClinicalTrials.gov Identifier: NCT03960203
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Dascena

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
In-hospital mortality [ Time Frame: 1 year ]
Rate of in-hospital mortality based on SIRS criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03960203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Hospital length of stay [ Time Frame: 1 year ]
    Duration of hospital length of stay in days based on SIRS criteria
  • 30-day readmissions [ Time Frame: 1 year ]
    Rate of patient readmissions within 30 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Sepsis Prediction Algorithm on Clinical Outcomes
Official Title  ICMJE Effect of a Sepsis Prediction Algorithm on Patient Mortality, Length of Stay, and Readmission
Brief Summary In this clinical outcomes analysis, the effect of a machine learning algorithm for severe sepsis prediction on in-hospital mortality, hospital length of stay, and 30-day readmission was evaluated.
Detailed Description Materials and Methods: Clinical outcomes evaluation performed on a multiyear, multicenter clinical data set of real-world data containing 75,147 patient encounters from nine hospitals. Mortality, hospital length of stay, and 30-day readmission analysis performed for 17,758 adult patients who met two or more Systemic Inflammatory Response Syndrome (SIRS) criteria at any point during their stay.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Severe Sepsis
Intervention  ICMJE Diagnostic Test: InSight
Clinical decision support (CDS) system for severe sepsis detection and prediction
Study Arms  ICMJE Experimental: Comparator
The comparator arm will involve patients monitored by InSight.
Intervention: Diagnostic Test: InSight
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
75147
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients over the age of 18 presenting to the emergency department or admitted to an inpatient unit at the participating facilities were automatically included for clinical outcomes analysis

Exclusion Criteria:

  • Patients under the age of 18
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960203
Other Study ID Numbers  ICMJE 05172019
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 Not Provided
Responsible Party Dascena
Study Sponsor  ICMJE Dascena
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ritankar Das, MSc Dascena
PRS Account Dascena
Verification Date May 2019

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