UMMS Sepsis Early Prediction Score (SEPSys) and RESCUE Score Combined Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Encounter is on a participating inpatient unit
Disqualifiers
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.
Trial design
Design model
Factorial
Treatments tested in this trial
SEPSys
DeviceThe 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
DeviceThe 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.
Treatment groups
150,000 Participants
are divided into 4 treatment groupsGroup A: SEPSysExperimental treatment 1 intervention
Group B: RESCUEExperimental treatment 1 intervention
Group C: SEPSys+RESCUEExperimental treatment 2 interventions
Group D: BaselineNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
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)).Secondary outcomes
1
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.
Time frame
Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).2
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.
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).3
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.
Time frame
Beginning at time of hospital admission and assessed continually until hospital discharge (average of 5 days).4
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.
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov