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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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This is a multicenter, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on ICU patients at risk of sepsis as an aid in identifying sepsis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: Blood sampling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Device | Daily blood sample which will be taken for the PSP measurement using the abioSCOPE as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]). |
| Measure | Description | Time Frame |
|---|---|---|
| Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis. | Assess the clinical sensitivity and specificity of the abioSCOPE PSP assay obtained on day 1 of ICU stay to identify sepsis within 3 days, based on EIRC assessment of sepsis. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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ICU admitted patients at risk of developing sepsis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41778855 | Derived | Shorr AF, Kollef MH, Wunderink RG, Jauregui-Peredo LE, Bernard AC, Kim HK, Balk RA, Cristofaro P, Levy MM. Diagnostic Performance of Point-of-Care Immunoassay Measurements of Pancreatic Stone Protein for Sepsis Detection in ICU Patients: A Prospective, Multicenter, Biomarker-Blinded Study. Crit Care Med. 2026 May 1;54(5):1147-1157. doi: 10.1097/CCM.0000000000007087. Epub 2026 Mar 4. |
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venous serum retained for future investigation related to sepsis biomarkers
|
| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Kentucky | Lexington | Kentucky | 40513 | United States |
| Mercy Health St. Vincent | Toledo | Ohio | 43608 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02904 | United States |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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