Sepsis
Conditions
Keywords
sepsis
Brief summary
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
Interventions
DIAGNOSTIC_TESTSepsis ImmunoScore
The 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.
Sponsors
Prenosis, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sepsis diagnosis | 24 hours | meeting sepsis-3 criteria within 24 hours of Sepsis ImmunoScore order |
| SEP-1 bundle compliance | through study completion, an average of 1 year | proportion of patients meeting SEP-1 bundle criteria for whom all bundle components are delivered within the required time frame |
| Number of clinically significant events such as infection, sepsis, critical care interventions, escalation of care, mortality | through study completion, an average of 1 year | (e.g., vasopressor support, renal replacement therapy, non-invasive or invasive respiratory ventilation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to antibiotic administration | through study completion, an average of 1 year | — |
| Coding compliance including appropriate clinical documentation to justify a diagnosis of sepsis | through study completion, an average of 1 year | — |
| Hospital length of stay | through study completion, an average of 1 year | — |
| ICU length of stay | through study completion, an average of 1 year | — |
| Total charges | through study completion, an average of 1 year | — |
| In-hospital mortality rate | through study completion, an average of 1 year | 28-day in-hospital mortality rate defined as the proportion of patients with a discharge disposition of "died" prior to 28 days |
Contacts
CONTACTGrace Staples
Outcome results
None listed