Sepsis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTNuQ H3.1 Nucleosome Assay
Serial analysis on whole blood of nucleosome levels until resolution of sepsis or discharge.
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Volition Diagnostics UK Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients must be at least 18 years of age to be included in the study. * Patients must have been admitted to critical care emergently with signs and symptoms consistent with a possible diagnosis of sepsis: defined as one of these types of infections: respiratory system, renal and genito-urinary system, gastrointestinal and intra-abdominal system, central nervous system, musculoskeletal, sepsis or fever of unknown origin * A 'comparator' arm will be included of patients aged over 18yrs of age undergoing planned elective coronary artery bypass graft surgery with anticipated post-operative care in critical care unit
Exclusion criteria
* Any subject not meeting the criteria above. * Patients who are re-admitted to intensive care unit within the same hospital admission * The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the levels of H3.1 nucleosomes in critically ill patients diagnosed with sepsis. | 14 days | 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. |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed