Performance and Impact of the Sepsis ImmunoScore
ConditionSepsis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPrenosis, Inc.
About this trial
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (age 18 years or older) patients presenting to hospitals and emergency departments of medical institutions across the United States.
Adult (age 18 years or older) patients suspected of sepsis.
Disqualifiers
none
Trial population
Adults 18 years or older presenting to the hospital or ED, suspected of clinically significant events, including sepsis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sepsis ImmunoScore
Diagnostic testThe Sepsis ImmunoScore is a risk stratification tool that uses Artificial Intelligence/Machine Learning to aid in the identification of patients likely to have or progress to sepsis within 24 hours of assessment.
Treatment groups
5,000 Participants
are divided into 2 treatment groupsGroup A: Adult patients at risk of clinically significant events0 interventions
Group B: Adult patients suspected of sepsis1 intervention
Trial outcomes
Primary outcomes
1
Sepsis diagnosis
meeting sepsis-3 criteria within 24 hours of Sepsis ImmunoScore order
Time frame
24 hours2
SEP-1 bundle compliance
proportion of patients meeting SEP-1 bundle criteria for whom all bundle components are delivered within the required time frame
Time frame
through study completion, an average of 1 year3
Number of clinically significant events such as infection, sepsis, critical care interventions, escalation of care, mortality
(e.g., vasopressor support, renal replacement therapy, non-invasive or invasive respiratory ventilation)
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Time to antibiotic administration
Time frame
through study completion, an average of 1 year2
Coding compliance including appropriate clinical documentation to justify a diagnosis of sepsis
Time frame
through study completion, an average of 1 year3
Hospital length of stay
Time frame
through study completion, an average of 1 year4
ICU length of stay
Time frame
through study completion, an average of 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: