MedPath

Unsupervised Machine Learning for Clustering of Septic Patients to Determine Optimal Treatment

Phase 2
Conditions
Septic Shock
Sepsis
Severe Sepsis
Interventions
Diagnostic Test: InSight
Diagnostic Test: Treatment-specific InSight
Registration Number
NCT03752489
Lead Sponsor
Dascena
Brief Summary

The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a fluid treatment-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, reductions in in-hospital mortality.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
51645
Inclusion Criteria
  • All adults above age 18 who are a member of one of the clinical subpopulations studied in this trial are eligible to participate in the study.
Exclusion Criteria
  • Under age 18

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard InSightInSightThe control arm will involve patients monitored with the standard, non-treatment specific version of InSight.
Fluid treatment-specific algorithmTreatment-specific InSightThe experimental arm will involve patients monitored by the fluid treatment-customized version of InSight.
Primary Outcome Measures
NameTimeMethod
In-hospital SIRS-based mortalityThrough study completion, an average of 8 months

Mortality attributed to patients meeting two or more SIRS criteria at some point during their stay

Secondary Outcome Measures
NameTimeMethod
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