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
• Interventions: Device: Morley Medical Sepsis Software Device

• 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

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-10-28
• Last Update Posted: 2020-10-28
• Study Start: 2020-10-31
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

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

Arm && Interventions

Group	Intervention	Description
Investigational Arm	Morley Medical Sepsis Software Device	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.

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