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CompletedNCT05922371EPICETUSUpdated Jun 4, 2026

ObsErvational Study of the Practical Cinical UTility of the NuQ.® H3.1 Nucleosome Levels in Adult Patients With Sepsis to Facilitate Early Diagnosis and Prognostication. (EPICETUS)

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sepsis

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03

In context

Sepsis

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 →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

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

Exclusion Criteria:

  • Any subject not meeting the criteria above.
  • Patients who are re-admitted to intensive care unit within the same hospital admission
  • The exclusion criteria are designed to remove confounding effects from concomitant conditions that may render the interpretation of the NuQ.® H3.1 assay impossible. These circumstances are few, but exclusions will include patients with limitations of care, including 'Do not attempt resuscitation' orders.
  • Patients with severe anaemia (as defined by a Hb\<50g/dL) will be excluded.
  • Subjects with any other severe concurrent disease that, in the judgment of the Principal Investigator, would make the subject inappropriate for entry into this study.
  • Patients in the 'comparator' arm who are undergoing cardiac surgery will be excluded if they have an active infection and specifically patients with a suspected or confirmed diagnosis of infective endocarditis.
  • Any patient undergoing cardiac surgery with a condition that might influence their immune response will be excluded. These include but are not limited to uncontrolled HIV, AIDS, uncontrolled systemic lupus erythematosus, rheumatoid arthritis or mixed connective tissue disorder, previous cancer and previous treatment with chemotherapy or the recipient of a solid organ or bone marrow transplant.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No

Groups and cohorts

  • Sepsis

    Adult patients admitted to critical care with a presumed diagnosis of sepsis.

    Diagnostic Test: NuQ H3.1 Nucleosome Assay

  • Cardiac surgery

    Adult cardiac surgery patients that are free from infection undergoing their first cardiac surgery.

    Diagnostic Test: NuQ H3.1 Nucleosome Assay

Interventions

  • Diagnostic testNuQ H3.1 Nucleosome Assay

    Serial analysis on whole blood of nucleosome levels until resolution of sepsis or discharge.

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

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Study locations

1 site
  • Guy's & St Thomas' NHS Foundation Trust
    London, London SE1 9RT, United Kingdom
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05922371
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
Volition Diagnostics UK Ltd
Responsible party
Sponsor
First posted
Jun 28, 2023
Start date
Dec 18, 2023
Primary completion
Jul 4, 2025
Completion
Jul 4, 2025
Last update
Jun 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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