Not a traditional drug phase: SEPSys for Sepsis
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.
Official registry: https://clinicaltrials.gov/study/NCT06779617 · University of Maryland, Baltimore · enrollment listed as 150,000
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are SEPSys, or RESCUE. The registry lists allocation as randomized. 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).
They plan to enroll about 150,000 people at 8 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
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
Interventions: SEPSys, RESCUE
Primary outcome (registry wording): Time To Vital Sign Measurement
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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 who can join:
- 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)
Who the registry excludes
- People the protocol lists as excluded — the study team must confirm.
Public study contact (from the registry)
Samuel A Tisherman, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
8 listed- University of Maryland Medical Center - Midtown — Baltimore, Maryland (recruiting)
- University of Maryland Medical Center — Baltimore, Maryland (recruiting)
- University of Maryland Upper Chesapeake Medical Center — Bel Air, Maryland (not_yet_recruiting)
- University of Maryland Shore Medical Center — Easton, Maryland (recruiting)
- University of Maryland Baltimore Washington Medical Center — Glen Burnie, Maryland (recruiting)
- University of Maryland Charles Regional Medical Center — La Plata, Maryland (recruiting)
- University of Maryland Capital Region Medical Center — Largo, Maryland (recruiting)
- University of Maryland St. Joseph Medical Center — Towson, Maryland (not_yet_recruiting)
FAQ about this NCT record
Is NCT06779617 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06779617?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06779617?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary