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| Name | Class |
|---|---|
| Intermountain Health Care, Inc. | OTHER |
| Johns Hopkins University | OTHER |
| Rush University Medical Center | OTHER |
| Northwell Health |
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The investigators seek to evaluate a new test for determining presence of infection/sepsis as compared to non-infection/systemic inflammatory response syndrome among critically ill patients within the first 24 hours of their being hospitalized in an intensive care unit (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2) existing clinical parameters. The investigators also hope to assess how well a related, new blood test, SeptID® identifies different types of infection, as compared to cultures and other lab tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill patients sepsis suspected |
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| Measure | Description | Time Frame |
|---|---|---|
| SeptiCyte® Lab score | Subjects will be followed for the duration of their hospital stay, an expected average of 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of SeptiCyte® Lab score to Leukocytosis, Bandemia, & procalcitonin | Subjects will be followed for the duration of their hospital stay, an expected average of 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| SeptID® results | Subjects will be followed for the duration of their hospital stay, an expected average of 7 days. |
Inclusion Criteria:
18-89 years old on the day of ICU admission
SIRS present as defined by the presence of two or more of the following:
Exclusion Criteria:
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Critically ill subjects, admitted to an Intensive Care Unit
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| Name | Affiliation | Role |
|---|---|---|
| Russell R. Miller, MD, MPH | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30828456 | Derived | Lopansri BK, Miller Iii RR, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Balk R, Greenberg JA, Yoder M, Patel GP, Gilbert E, Afshar M, Parada JP, Martin GS, Esper AM, Kempker JA, Narasimhan M, Tsegaye A, Hahn S, Mayo P, McHugh L, Rapisarda A, Sampson D, Brandon RA, Seldon TA, Yager TD, Brandon RB. Physician agreement on the diagnosis of sepsis in the intensive care unit: estimation of concordance and analysis of underlying factors in a multicenter cohort. J Intensive Care. 2019 Feb 21;7:13. doi: 10.1186/s40560-019-0368-2. eCollection 2019. | |
| 29624409 |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| Loyola University | OTHER |
| Grady Memorial Hospital | OTHER |
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Blood samples will be collected
| Chicago |
| Illinois |
| 60612 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| Northwell Health | New Hyde Park | New York | 11040 | United States |
| Intermountain Medical Center | Murray | Utah | 84157-7000 | United States |
| Derived |
| Miller RR 3rd, Lopansri BK, Burke JP, Levy M, Opal S, Rothman RE, D'Alessio FR, Sidhaye VK, Aggarwal NR, Balk R, Greenberg JA, Yoder M, Patel G, Gilbert E, Afshar M, Parada JP, Martin GS, Esper AM, Kempker JA, Narasimhan M, Tsegaye A, Hahn S, Mayo P, van der Poll T, Schultz MJ, Scicluna BP, Klein Klouwenberg P, Rapisarda A, Seldon TA, McHugh LC, Yager TD, Cermelli S, Sampson D, Rothwell V, Newman R, Bhide S, Fox BA, Kirk JT, Navalkar K, Davis RF, Brandon RA, Brandon RB. Validation of a Host Response Assay, SeptiCyte LAB, for Discriminating Sepsis from Systemic Inflammatory Response Syndrome in the ICU. Am J Respir Crit Care Med. 2018 Oct 1;198(7):903-913. doi: 10.1164/rccm.201712-2472OC. |
| D012769 | Shock |