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Predictive algoRithm for EValuation and Intervention in SEpsis (PREVISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03235193
Recruitment Status : Unknown
Verified August 2017 by Dascena.
Recruitment status was:  Recruiting
First Posted : August 1, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
Cabell Huntington Hospital
Information provided by (Responsible Party):
Dascena

Tracking Information
First Submitted Date  ICMJE July 27, 2017
First Posted Date  ICMJE August 1, 2017
Last Update Posted Date August 3, 2017
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2017)
In-hospital mortality [ Time Frame: Through study completion, an average of 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2017)
Hospital length of stay [ Time Frame: Through study completion, an average of 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 27, 2017)
  • Hospital readmission [ Time Frame: Through study completion, an average of 30 days ]
  • ICU length of stay [ Time Frame: Through study completion, an average of 30 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Predictive algoRithm for EValuation and Intervention in SEpsis
Official Title  ICMJE Prediction of Severe Sepsis Using a Machine Learning Algorithm
Brief Summary In this prospective study, the ability of a machine learning algorithm to predict sepsis and influence clinical outcomes, will be investigated at Cabell Huntington Hospital (CHH).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Sepsis
  • Septic Shock
  • Severe Sepsis
Intervention  ICMJE
  • Other: Severe Sepsis Prediction
    Upon receiving an InSight alert, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.
  • Other: Severe Sepsis Detection
    Upon receiving information from the severe sepsis detector in the CHH electronic health record, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.
Study Arms  ICMJE
  • Experimental: With InSight
    Healthcare provider receives an alert from InSight for patients trending towards severe sepsis. Healthcare provider also receives information from the severe sepsis detector in the CHH electronic health record.
    Interventions:
    • Other: Severe Sepsis Prediction
    • Other: Severe Sepsis Detection
  • Active Comparator: Without Insight
    Healthcare provider does not receive any alerts from InSight. Healthcare provider receives information from the severe sepsis detector in the CHH electronic health record.
    Intervention: Other: Severe Sepsis Detection
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 27, 2017)
1241
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All adult patients visiting the emergency department, or admitted to the participating intensive care unit (ICU) wards of Cabell Huntington Hospital will be eligible.

Exclusion Criteria:

  • All patients younger than 18 years of age will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03235193
Other Study ID Numbers  ICMJE 1097090-1
Has Data Monitoring Committee Not Provided
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 Cabell Huntington Hospital
Investigators  ICMJE
Principal Investigator: Hoyt Burdick Cabell Huntington Hospital
PRS Account Dascena
Verification Date August 2017

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