UMMS Sepsis Early Prediction Score (SEPSys) and RESCUE Score Combined Clinical Trial

NCT06779617 | Recruiting FDA Device

• 1 other identifier: HP-00109072
• Study Type: interventional
• Target: 150,000
• Locations: 1 country
• Sites: 8

Brief Summary

This study is designed to test two new risk scores - one designed to predict a patient's four-hour risk of developing sepsis and one designed to predict a patient's four-hour risk of deterioration (cardiac arrest, death, unplanned ICU transfer, or rapid response team call). The goal of this study is to improve provider awareness of a patient's risk of these two negative outcomes by providing them with new risk scores. The primary outcome will be the time from when the risk score becomes elevated to when vital signs such as heart rate or blood pressure are measured, suggesting an increased awareness.

Conditions

Sepsis; Patient Deterioration

Keywords

Sepsis; Patient Deterioration; AI; Artificial Intelligence; Machine learning; Decision support; Clinical decision support; Early warning systems

Outcome Measures

Primary Outcomes (1)

• Time To Vital Sign Measurement

  Time to vital sign measurement after elevation of either the Sepsis Early Prediction System (SEPSys) or RESCUE Score. An elevated SEPSys or RESCUE Score is defined as a current SEPSys or RESCUE Score of 3 or 4 (highest risk) when the previous Score was a 1 (lowest risk) or 2.

  From time of elevation of either the Sepsis Early Prediction System (SEPSys) or RESCUE Score to measurement of vital signs, assessed continually during the hospitalization (up to 24 hours after the elevation)).

Secondary Outcomes (4)

• Sepsis diagnosis

  Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).

• Time to sepsis-specific treatment

  From time of elevation of the SEPSys Score to initiation of sepsis-specific antibiotics or fluid bolus, assessed continually during the hospitalization (up to 96 hours).

• Deterioration Events

  Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).

• Frequency of laboratory orders

  From time of elevation of either the Sepsis Early Prediction System (SEPSys) or RESCUE Score to measurement of laboratory orders, assessed continually during the hospitalization (up to 24 hours).

Study Arms (4)

SEPSys

EXPERIMENTAL

Cluster has SEPSys Score only

Device: SEPSys

RESCUE

EXPERIMENTAL

Cluster has RESCUE Score only

Device: RESCUE

SEPSys+RESCUE

EXPERIMENTAL

Cluster has both SEPSys \& RESCUE Scores

Device: SEPSys; Device: RESCUE

Baseline

NO INTERVENTION

Cluster has neither SEPSys nor RESCUE

Interventions

SEPSys DEVICE

The SEPSys Score is a clinical decision support tool for predicting the risk of developing sepsis in the next 4 hours. The SEPSys Score produces a 1-4, color-coded risk, where 4 (red) is the highest risk and 1 (green) is the lowest risk.

SEPSys; SEPSys+RESCUE

RESCUE DEVICE

The RESCUE Score is a clinical decision support tool for predicting the risk of patient experiencing clinical deterioration (cardiac arrest, rapid response team call, death, or unplanned increase in care) in the next 4 hours. The RESCUE Score produces a 1-4, color-coded risk, where 4 (red) is the highest risk and 1 (green) is the lowest risk.

RESCUE; SEPSys+RESCUE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Units are part of a member hospital of the University of Maryland Medical System (UMMS)
• Units treat inpatient patients
• Units agree to participate in the study
• Encounter is on a participating inpatient unit
• Encounter is associated with a bedded patient in the hospital
• Encounter is associated with an adult (at least 18 years of age at time of admission)
• Encounter has a SEPSys Score
• Encounter has a RESCUE Score

You may not qualify if:

• Unit treats exclusively outpatients or is located in an outpatient setting
• Unit treats primarily or exclusively pediatric patients (patients under the age of 18 years old)
• Unit treats exclusively psychiatric patients
• Encounter is with OB for a normal delivery and the patient has yet to give birth. This encounter can become eligible once the patient has given birth.
• Encounter is admitted with a diagnosis of sepsis
• Sepsis was already diagnosed during the encounter
• This encounter will have been eligible until the patient began showing clinical signs or symptoms of sepsis or received a diagnosis of sepsis. Once they have a diagnosis or clinical signs or symptoms of sepsis, their SEPSys Score will no longer be updated. Data will continue to be collected on time of laboratory orders and treatments.
• Encounter is admitted with a high RESCUE Score (RESCUE Score of 4)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (8)

University of Maryland Medical Center - Midtown

Baltimore, Maryland, 21201, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

University of Maryland Upper Chesapeake Medical Center

Bel Air, Maryland, 21014, United States

NOT YET RECRUITING

University of Maryland Shore Medical Center

Easton, Maryland, 21601, United States

NOT YET RECRUITING

University of Maryland Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

NOT YET RECRUITING

University of Maryland Charles Regional Medical Center

La Plata, Maryland, 20646, United States

NOT YET RECRUITING

University of Maryland Capital Region Medical Center

Largo, Maryland, 20774, United States

RECRUITING

University of Maryland St. Joseph Medical Center

Towson, Maryland, 21204, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Samuel A Tisherman, MD

CONTACT

410-328-9114; stisherman@som.umaryland.edu

Jason Heavner, MD

CONTACT

410-553-8240; jason.heavner@umm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery and the Program in Trauma

Model Details: This is a 2-intervention + control cluster-randomized factorial stepped wedge design clinical trial

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 16, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)