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| Name | Class |
|---|---|
| Morley Research Consortium | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Arm | Experimental | The patients enrolled into the investigational arm at each participating hospital will be monitored with the Morley Medical Sepsis (MMS) Software Device for the prediction and early identification of sepsis. |
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| Control Arm | No Intervention | The patients enrolled into the control group of each participating hospital will not be monitored with the Morley Medical Sepsis (MMS) Software Device for the prediction and early identification of sepsis. These patients will be monitored according to each institution's standard sepsis screening practices. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morley Medical Sepsis Software Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital sepsis prevalence | Up to 8 weeks | |
| In-hospital sepsis related 30-day mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital all-cause 30-day mortality | 30 days | |
| Hospital length of stay | Up to 8 weeks | |
| Hospital re-admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kiki Diorgu, MD, MBA | Contact | 4048911750 | adiorgu@morleymed.com |
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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.
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| 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 |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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