UMMS Sepsis Early Prediction Score (SEPSys) and RESCUE Score Combined Clinical Trial
NCT06779617 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150000
Last updated 2026-05-05
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
Interventions
- DEVICE
-
SEPSys
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.
- DEVICE
-
RESCUE
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.
Sponsors & Collaborators
-
University of Maryland, Baltimore
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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