NCT07184593Not yet recruiting
Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients
Validation of a Point-of-care Device for Rapid Bedside Measurement of Circulating Nucleosome Levels in Critically Ill Patients and Study of Its Relevance to Prognostication
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
NUROPI is a single-centre, prospective, non-interventional study in the Intensive Care Unit (ICU) of Erasme Hospital (Hôpital Universitaire de Bruxelles, Brussels, Belgium). Some critically ill patients get worse during the first days of their ICU stay. Identifying them early could allow faster escalation of care. Nucleosomes are fragments of DNA wrapped around proteins called histones. They are released into the blood when cells die or when white blood cells form neutrophil extracellular traps (NETs). High blood levels of nucleosomes may reflect inflammation, clotting activation and organ damage. This study will measure the H3.1 nucleosome in the blood of 1,000 consecutive adult ICU patients. The measurement uses a CE-marked laboratory test (Nu.Q® NETs, chemiluminescence immunoassay on the IDS-i10 analyser). No additional blood sample is taken for the study. H3.1 is measured on the leftover plasma of blood samples already drawn for routine care, at ICU admission, 6 hours, day 1, day 3 and day 7. Patient treatment is not changed. Patients, or their relatives or legal representative, receive an information notice and may refuse participation at any time. The main question is whether H3.1, alone or combined with routine ICU data, can identify patients at high risk of clinical deterioration within 72 hours of ICU admission. Other questions concern the link between H3.1 and mortality, organ dysfunction, and ICU treatments, and how H3.1 levels change during the first week.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Erasme University Hospital
- NCT number
- NCT07184593
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Oct 2026 to the primary completion date, 30 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Readmission to the ICU of a previously enrolled patient
Other
- Imminent death (life expectancy less than 24 hours)
- Therapeutic limitations at ICU admission (e.g., no indication for intubation, comfort care only)
- Absence of an arterial catheter or central venous catheter
- ICU admission more than 24 hours before screening
- Opposition to participation expressed by the patient or their legal representative
Who the study is looking for
- Age 18 years or older
- Admission to the ICU of Erasme Hospital within the previous 24 hours, regardless of admission diagnosis
- Arterial catheter or central venous catheter already in place for clinical reasons
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.