Sepsis
Conditions
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.
Interventions
DEVICEMorley Medical Sepsis Software Device
The Morley Medical Sepsis (MMS) Software Device is a predictive analytics, stand-alone, cloud-based software system with no hardware components. The software acquires patient data from the electronic medical record, processes the data using unique artificial intelligence (AI) powered algorithms, and generates clinical decision support outputs that aid in the proactive delivery of customized and efficient care for patients. The software output is made available to the end users (trained medical professionals) via an intuitive user interface displayed on desktop computers or mobile communication devices such as laptops, smartphones or tablets.
Sponsors
Morley Research Consortium
Morley Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a pivotal medical device clinical trial comparing the clinical outcomes in hospitalized patients monitored with the MMS Software Device for the prediction and early detection of sepsis versus patients monitored with current standard sepsis scoring systems at participating clinical trial sites. This will be conducted through a non-randomized multi-center, non-blinded, clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-hospital sepsis prevalence | Up to 8 weeks |
| In-hospital sepsis related 30-day mortality | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 |
| Time of initial antibiotics administration | Day 1 to Day 30, or until discharge |
| In-hospital all-cause 30-day mortality | 30 days |
Contacts
Primary ContactKiki Diorgu, MD, MBA
Outcome results
None listed