Evaluating a blood test for early diagnosis of sepsis in critically ill patients
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)
This study is testing a new blood test to see if it can help doctors quickly diagnose sepsis in critically ill patients compared to those having heart surgery without infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT05922371 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic performance of the NuQ.® H3.1 nucleosome assay in adult patients admitted to critical care with signs of potential sepsis. The study will compare these patients to a control group of adult surgical patients undergoing elective cardiac surgery who are free from infection. By measuring circulating nucleosome levels in plasma, the study seeks to enhance early detection and prognostication of sepsis, potentially improving patient outcomes. The study is conducted at a single center and involves a prospective design.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are admitted to critical care with signs of possible sepsis.
Not a fit: Patients who are re-admitted to the intensive care unit within the same hospital admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of sepsis, improving treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using similar biomarkers for diagnosing sepsis, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
London
- Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Andrew Retter, MBBS
- Email: Andrew.Retter@gstt.nhs.uk
- Phone: 07837945067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.