A Clinical Trial to Evaluate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in Predicting Sepsis in Adult Patients Using Artificial Intelligence (AI) Machine Learning Algorithms
Not Applicable
- Conditions
- Sepsis
- Registration Number
- NCT04606862
- Lead Sponsor
- Morley Medical
- Brief Summary
This is a pivotal medical device clinical trial evaluating the clinical outcomes in hospitalized patients monitored with the Morley Medical Sepsis Software Device. The device uses unique AI machine learning algorithms to analyze patient data in real time and generate clinical decision support sepsis risk predictions for clinicians.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
Inclusion Criteria
- Male or female patient 18 years of age or older
- Patient is admitted or had been admitted to a participating healthcare facility
Exclusion Criteria
- Sepsis diagnosis present on admission
- Involvement in a clinical trial of another investigational product with similar purpose
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method In-hospital sepsis prevalence Up to 8 weeks In-hospital sepsis related 30-day mortality 30 days
- Secondary Outcome Measures
Name Time Method In-hospital all-cause 30-day mortality 30 days Hospital length of stay Up to 8 weeks Hospital re-admission Up to 8 weeks Time of initial IV fluids administration Day 1 to Day 30, or until discharge Time of initial vasopressors administration Day 1 to Day 30, or until discharge Time of initial antibiotics administration Day 1 to Day 30, or until discharge Time of initial blood microbiology culture Day 1 to Day 30, or until discharge Sepsis related adverse outcomes (septic shock) Day 1 to Day 30, or until discharge Sepsis prediction to onset time Day 1 to Day 30, or until discharge Sensitivity and specificity of sepsis prediction Day 1 to Day 30, or until discharge
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie sepsis risk prediction using Morley Medical Sepsis Software Device's AI algorithms?
How does the Morley Medical Sepsis Software Device compare to standard-of-care sepsis detection methods in clinical outcomes?
Which biomarkers are integrated into the Morley Medical Sepsis Software Device for early sepsis detection and patient stratification?
What adverse events are associated with AI-based sepsis prediction tools like the Morley Medical Sepsis Software Device in hospitalized adults?
Are there combination approaches or competing devices that enhance sepsis prediction when used alongside the Morley Medical Sepsis Software Device?