An observational study in Sepsis, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
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.
1,899 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's enrollment of 34 is below the median of 160 across 929 observational studies indexed under Sepsis.
Browse Sepsis studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.
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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.
Exclusion Criteria:
Adult patients admitted to critical care with a presumed diagnosis of sepsis.
Diagnostic Test: NuQ H3.1 Nucleosome Assay
Adult cardiac surgery patients that are free from infection undergoing their first cardiac surgery.
Diagnostic Test: NuQ H3.1 Nucleosome Assay
Serial analysis on whole blood of nucleosome levels until resolution of sepsis or discharge.
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.
Time frame: 14 days
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.
Time frame: 90 days
Plan to share: Undecided
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust