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| Name | Class |
|---|---|
| Volition Diagnostics UK Ltd | UNKNOWN |
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This is a study to evaluate the diagnostic performance of the investigation NuQ. (R) H3.1 nucleosome assay as a diagnostic marker of sepsis in a population of patients admitted to critical care with signs suspicious of infection and consistent with the sepsis 3 definition. These patients will be compared to a group of adult surgical patients free from infection that are undergoing their first cardiac surgery.
This is a single centre, prosepctive study to evaluate the diagnostic performance of the investigation NuQ. (R) H3.1 nucleosome assay as a diagnostic marker of sepsis in a population of patients admitted to critical care with signs suspicious of infection and consistent with the sepsis 3 definition. The H3.1 assay is a chemiluminescent sandwich immunoassay for the detection of nucleosomes circulating in human plasma. The test quantifies the level of circulating nucleosomes and in conjunction with other laboratory findings and clinical assessment aids in the early detection of sepsis with organ dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sepsis | Adult patients admitted to critical care with a presumed diagnosis of sepsis. |
| |
| Cardiac surgery | Adult cardiac surgery patients that are free from infection undergoing their first cardiac surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuQ H3.1 Nucleosome Assay | Diagnostic Test | Serial analysis on whole blood of nucleosome levels until resolution of sepsis or discharge. |
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| Measure | Description | Time Frame |
|---|---|---|
| To investigate the levels of H3.1 nucleosomes in critically ill patients diagnosed with sepsis. | To investigate the levels of H3.1 nucleosomes in critically ill patients diagnosed with sepsis or septic shock (as defined by Sepsis-3 criteria at time of presentation), specifically to monitor how these levels change over time in relation to disease progression, clinical data and other routinely collected biomarkers such as CRP and procalcitonin. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the potential utility of levels of NETs/Cf DNA (as measured by the H3.1 nucleosome assay) as a companion diagnostic test of septic shock, disease monitoring, severity and prognosis. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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The participants will be recruited into two cohorts. The first cohort are patients who require critical care admission emergently from either A&E or other hospital ward with a presumed diagnosis of sepsis. The second group consists of patients who have a planned elective cardiac surgery (Coronary Artery By-Pass Graft surgery) and require critical care admission post operatively as part of the planned surgery. These patients have been selected to describe how the level of NuQ.® H3.1 alters over time after the sterile insult of cardiac surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's & St Thomas' NHS Foundation Trust | London | London | SE1 9RT | United Kingdom |
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| 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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