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

Morley Medical10,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

10,000

Conditions

Sepsis

Interventions

Morley Medical Sepsis Software DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Time frame: 30 days

Hospital length of stay

Time frame: Up to 8 weeks

Hospital re-admission

Time frame: Up to 8 weeks

Time of initial IV fluids administration