SepsisNCT06779617
UMMS Sepsis Early Prediction Score (SEPSys) and RESCUE Score Combined Clinical Trial
A study testing SEPSys and RESCUE in people with Sepsis and Patient Deterioration, run by University of Maryland, Baltimore at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Patient Deterioration
- What is being tested?
- SEPSys and RESCUE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150,000 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Feb 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 11Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
University of Maryland Medical Center - Midtown
Baltimore, Maryland, 21201
- Not yet recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
- Not yet recruiting
University of Maryland Upper Chesapeake Medical Center
Bel Air, Maryland, 21014
- Not yet recruiting
University of Maryland Shore Medical Center
Easton, Maryland, 21601
- Not yet recruiting
University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
- Not yet recruiting
University of Maryland Charles Regional Medical Center
La Plata, Maryland, 20646
- Recruiting
University of Maryland Capital Region Medical Center
Largo, Maryland, 20774
- Not yet recruiting
University of Maryland St. Joseph Medical Center
Towson, Maryland, 21204
About this study
Official title: Full Title: Sepsis Early Prediction System Score (SEPSys Score) and RESCUE Score Multi-Site, Two-Intervention, Cluster-Randomized, Factorial Stepped-Wedge Pragmatic Clinical Trial at the University of Mayland Medical System
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.
Read the detailed description
The University of Maryland Medical System is conducting a study 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 (death, cardiac arrest, unplanned ICU transfer, or rapid response call). The goal of this study is to improve provider awareness of a patient's risk of these two negative outcomes, sepsis and deterioration, by providing them with new risk scores. To assess provider awareness of risk, this study will measure time from elevated risk score to measurement of vital signs, such as heart rate or blood pressure with the hope that increased awareness of risk will decrease time to vital sign measurement, indicating closer monitoring.
The first risk score, the RESCUE Score, produces a highly accurate 1-4 color-coded risk score where a 1 indicates that a patient has a low risk of having a deterioration event in the next four hours and a 4 indicates that the patient has a high risk of having a deterioration event in the next four hours. The second risk score, the SEPSys Score, produces a highly accurate 1-4 color coded risk score where 1 indicates that a patient has a low risk of developing sepsis in the next 4 hours and a 4 indicates that the patient has a high risk of developing sepsis in the next 4 hours. Both of these scores are predictive of events that may happen in the future but are not detective or diagnostic of events that are actively occurring.
In this study, hospitals will be randomized for the order in which they cross-over from the control arm (no risk score) to either having the SEPSys or RESCUE Score visible for their inpatients. After a few months with an individual risk score, the second risk score will be added. Thus, at the beginning of the study, no hospitals with have the new risk scores available, for a period in the middle of the study each hospital will have one risk score available, and by the end of the study all hospitals will have both risk scores available. Regardless of which risk scores are available, the clinicians will be free to recommend treatments and implement care plans using their own judgement. No procedures impacting patient care will be specified for this study.
- Conditions
- Sepsis, Patient Deterioration
- Being tested
- SEPSys, RESCUE
- Keywords
- Sepsis, Patient Deterioration, AI, Artificial Intelligence, Machine learning, Decision support, Clinical decision support, Early warning systems
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEPSysDevice
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.
RESCUEDevice
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 group | Role | What they receive |
|---|---|---|
| SEPSys | Experimental | Cluster has SEPSys Score only Receives: Device: SEPSys |
| RESCUE | Experimental | Cluster has RESCUE Score only Receives: Device: RESCUE |
| SEPSys+RESCUE | Experimental | Cluster has both SEPSys \& RESCUE Scores Receives: Device: SEPSys; Device: RESCUE |
| Baseline | No intervention | Cluster has neither SEPSys nor RESCUE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The patient develops sepsis during the hospitalization following elevation of the SEPSys 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.
Measured: Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).
Time to sepsis-specific treatment
Time from first elevated SEPSys Score to order/administration of sepsis indicated antibiotics or fluid bolus. 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.
Measured: 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
Binary outcome of deterioration event (cardiac arrest, death, rapid response team call, unplanned increase in level of care). 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.
Measured: Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).
Frequency of laboratory orders
Frequency of laboratory orders or measurements after an elevated 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a 2-intervention + control cluster-randomized factorial stepped wedge design clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Tisherman, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779617
- Sponsor's protocol ID
- HP-00109072
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Title: Sepsis Early Prediction System Score (SEPSys Score) and RESCUE Score Multi-Site, Two-Intervention, Cluster-Randomized, Factorial Stepped-Wedge Pragmatic Clinical Trial at the University of Mayland Medical System
- ClinicalTrials.gov ID
- NCT06779617
- Acronym / sponsor ID
- HP-00109072
- Conditions
- Sepsis, Patient Deterioration
- Keywords
- Sepsis, Patient Deterioration, AI, Artificial Intelligence, Machine learning, Decision support, Clinical decision support, Early warning systems
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150,000 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The University of Maryland Medical System is conducting a study 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 (death, cardiac arrest, unplanned ICU transfer, or rapid response call). The goal of this study is to improve provider awareness of a patient's risk of these two negative outcomes, sepsis and deterioration, by providing them with new risk scores. To assess provider awareness of risk, this study will measure time from elevated risk score to measurement of vital signs, such as heart rate or blood pressure with the hope that increased awareness of risk will decrease time to vital sign measurement, indicating closer monitoring.
The first risk score, the RESCUE Score, produces a highly accurate 1-4 color-coded risk score where a 1 indicates that a patient has a low risk of having a deterioration event in the next four hours and a 4 indicates that the patient has a high risk of having a deterioration event in the next four hours. The second risk score, the SEPSys Score, produces a highly accurate 1-4 color coded risk score where 1 indicates that a patient has a low risk of developing sepsis in the next 4 hours and a 4 indicates that the patient has a high risk of developing sepsis in the next 4 hours. Both of these scores are predictive of events that may happen in the future but are not detective or diagnostic of events that are actively occurring.
In this study, hospitals will be randomized for the order in which they cross-over from the control arm (no risk score) to either having the SEPSys or RESCUE Score visible for their inpatients. After a few months with an individual risk score, the second risk score will be added. Thus, at the beginning of the study, no hospitals with have the new risk scores available, for a period in the middle of the study each hospital will have one risk score available, and by the end of the study all hospitals will have both risk scores available. Regardless of which risk scores are available, the clinicians will be free to recommend treatments and implement care plans using their own judgement. No procedures impacting patient care will be specified for this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This is a 2-intervention + control cluster-randomized factorial stepped wedge design clinical trial
| Arm | Type | Receives |
|---|---|---|
| SEPSys | Experimental | Device: SEPSysCluster has SEPSys Score only |
| RESCUE | Experimental | Device: RESCUECluster has RESCUE Score only |
| SEPSys+RESCUE | Experimental | Device: SEPSys, Device: RESCUECluster has both SEPSys \& RESCUE Scores |
| Baseline | No intervention | –Cluster has neither SEPSys nor RESCUE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEPSysThe 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 | SEPSys, SEPSys+RESCUE |
| RESCUEThe 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. | Device | RESCUE, SEPSys+RESCUE |
Primary outcome
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)).
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.
4 secondary outcomes
Sepsis diagnosis
Time frame: Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).
Time to sepsis-specific treatment
Time frame: 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
Time frame: Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).
Frequency of laboratory orders
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEPSys and RESCUE in people with Sepsis and Patient Deterioration, run by University of Maryland, Baltimore at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel A Tisherman, MD (410-328-9114, stisherman@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.