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| Name | Class |
|---|---|
| University of Florida | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Patients with suspected sepsis at the time of admission to the ICU |
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| Arm B | Patients not currently suspected but at high risk for sepsis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HostDx Sepsis | Diagnostic Test | Blood collection for mRNA analysis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year |
| 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. | 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 | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year |
| 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. | Percentage of patients with correctly predicted outcomes using HostDx Sepsis (CCI), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year |
| 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. | Percentage of patients with correctly predicted outcomes using HostDx Sepsis (30-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year |
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Inclusion Criteria:
Arm A
Arm B
Exclusion Criteria:
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Subjects admitted to the surgical ICU with suspected sepsis or at high risk for subsequent sepsis onset.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida College of Medicine | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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The blood sample collection materials for the HostDx Sepsis test (PAXgene Blood RNA tubes) will be collected. EDTA tubes for plasma measurements of procalcitonin and IL-6 will be collected. Collection tubes for serum samples to measure viral antibodies and/or viral titers (indicative of reactivation of viral infection) will also be collected. These will be stored locally and processed at a later time point dependent on needs, i.e. suspicion of viral reactivation.
| 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. | Percentage of patients with correctly predicted outcomes using HostDx Sepsis (90-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |