NCT04606862UnknownNot Applicable
A Non-Randomized Clinical Trial to Investigate the Efficacy of the Morley Medical Sepsis (MMS) Software Device in the Prediction and Early Detection of Sepsis
Morley Medical0 sites10,000 target enrollmentStarted: October 31, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 10,000
- Primary Endpoint
- In-hospital sepsis prevalence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
In-hospital sepsis prevalence
Time Frame: Up to 8 weeks
In-hospital sepsis related 30-day mortality
Time Frame: 30 days
Secondary Outcomes
- 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)
Investigators
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