Recruiting

Risk Scores

Sponsor:

University of Maryland, Baltimore

Code:

NCT06779617

Conditions

Sepsis

Patient Deterioration

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SEPSys

RESCUE

Study Details

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

Study ID

NCT06779617

Start date

Feb 1, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Hospital Unit Inclusion Criteria:

  • 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

General Encounter Inclusion Criteria:

  • 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)

Additional SEPSys Encounter Inclusion Criteria:

• Encounter has a SEPSys Score

Additional RESCUE Encounter Inclusion Criteria:

• Encounter has a RESCUE Score

Exclusion Criteria:

Hospital Unit Exclusion Criteria:

  • 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

Additional SEPSys Encounter Exclusion Criteria:

  • 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.

Additional RESCUE Encounter Exclusion Criteria:

• Encounter is admitted with a high RESCUE Score (RESCUE Score of 4)

Study Design

Enrollment

150000 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

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.

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.

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 and Locations

Central contacts

Locations

University of Maryland Medical Center - Midtown

Recruiting

Baltimore, Maryland, United States, 21201

University of Maryland Capital Region Medical Center

Recruiting

Largo, Maryland, United States, 20774

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-05-05.