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)
EPICETUS
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedStudy Start
First participant enrolled
December 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedApril 3, 2024
June 1, 2023
1.1 years
June 19, 2023
April 2, 2024
Conditions
Outcome Measures
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.
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.
90 days
Study Arms (2)
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.
Interventions
Serial analysis on whole blood of nucleosome levels until resolution of sepsis or discharge.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Any subject not meeting the criteria above.
- Patients who are re-admitted to intensive care unit within the same hospital admission
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2023
First Posted
June 28, 2023
Study Start
December 18, 2023
Primary Completion
February 1, 2025
Study Completion
March 1, 2025
Last Updated
April 3, 2024
Record last verified: 2023-06