Sepsis
Conditions
Brief summary
This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU
Interventions
DIAGNOSTIC_TESTHostDx Sepsis
Blood collection for mRNA analysis
Sponsors
University of Florida
Inflammatix
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Arm A 1. Age \> 18 years 2. Suspected sepsis at the time of admission to the ICU 3. Direct admission from the ED to the ICU with suspected/proven sepsis. 4. Post-operative ICU admission after sepsis source control procedure 5. Inpatients admitted to the ICU from the ward with suspected sepsis onset. 6. Able to provide subject/proxy informed consent within 96h Arm B 1. Age \> 18 years 2. No suspicion of sepsis at the time of admission to the ICU but at high risk for subsequent sepsis onset 3. Non-trauma admission from the ED to the ICU 4. Post-operative ICU admission 5. Severe trauma admission from the ED (injury severity score \>15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma) 6. Inpatients admitted to the ICU from the ward for decompensation not initially suspected to be secondary to sepsis. 7. Able to provide subject/proxy informed consent within 96h
Exclusion criteria
1. Pre- or post-transplant patients 2. Patients admitted solely for airway monitoring, or vascular/flap check monitoring 3. Previous diagnosis of sepsis on index hospitalization. 4. Unable to provide informed consent within 96h 5. Previously enrolled in the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis. | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year | Percentage of correctly identified patients with bacterial and/or viral infections using HostDx Sepsis compared to clinical adjudications using routine clinical, laboratory, and other findings |
| Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis. | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year | Percentage of patients with correctly predicted outcomes using HostDx Sepsis (7-day organ support), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis |
Countries
United States
Outcome results
None listed