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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06779617
Status
Recruiting
Apply to this trial

Conditions

  • Patient Deterioration
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
150,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: SEPSys
    Cluster has SEPSys Score only
  • Experimental: RESCUE
    Cluster has RESCUE Score only
  • Experimental: SEPSys+RESCUE
    Cluster has both SEPSys \& RESCUE Scores
  • No Intervention: Baseline
    Cluster has neither SEPSys nor RESCUE

Primary Outcome Measure

Time To Vital Sign Measurement [ Time Frame: 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)). ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21201-
University of Maryland Medical Center - MidtownBaltimoreMaryland21201-
University of Maryland Upper Chesapeake Medical CenterBel AirMaryland21014-
University of Maryland Shore Medical CenterEastonMaryland21601-
University of Maryland Baltimore Washington Medical CenterGlen BurnieMaryland21061-
University of Maryland Charles Regional Medical CenterLa PlataMaryland20646-
University of Maryland Capital Region Medical CenterLargoMaryland20774-
University of Maryland St. Joseph Medical CenterTowsonMaryland21204-

Find similar trials in Baltimore, MD

By research site
University of Maryland Medical Center· Baltimore, MDUniversity of Maryland Medical Center - Midtown· Baltimore, MDUniversity of Maryland Upper Chesapeake Medical Center· Bel Air, MDUniversity of Maryland Shore Medical Center· Easton, MDUniversity of Maryland Baltimore Washington Medical Center· Glen Burnie, MDUniversity of Maryland Charles Regional Medical Center· La Plata, MD

Related Studies