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Life sciences · Observational Study
ClinicalTrials.gov · September 22, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07184593). This is a study registration, not published results. Lead sponsor: Erasme University Hospital. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Sepsis, Septic Shock, Cardiac Arrest (CA), Pancreatitis, Acute Brain Injury, Trauma Blunt, Cardiogenic Shock. Interventions: DIAGNOSTIC_TEST: Plasma H3.1 nucleosome measurement. Primary outcome measures: Discriminative performance of admission plasma H3.1 for early clinical deterioration , From ICU admission to 72 hours. Brief summary: 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.