Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients

Sponsor
Erasme University Hospital
Study ID
NCT07184593
Status
Not Yet Recruiting

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Conditions

  • Acute Brain Injury
  • Cardiac Arrest (CA)
  • Cardiogenic Shock
  • Pancreatitis
  • Sepsis
  • Septic Shock
  • Trauma Blunt

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Plasma H3.1 nucleosome measurement — DIAGNOSTIC_TEST
    Measurement of circulating H3.1 nucleosomes by chemiluminescence immunoassay (Nu.Q® NETs on the IDS-i10 analyser, CE-marked in vitro diagnostic device) on residual plasma from routine K2-EDTA samples. No additional blood sampling is performed and results are not used for clinical management.

Study Details

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.

Key Dates

First listed
Sep 22, 2025
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Critically ill adults (all-comers)
    Consecutive adults (18 years or older) admitted to the Intensive Care Unit of Erasme Hospital within the previous 24 hours, all admission diagnoses combined, with an arterial or central venous catheter already in place for clinical reasons. Enrolment is capped at 20 neurosurgical and 50 cardiac-surgery patients. Plasma H3.1 is measured on residual routine samples at admission, 6 hours, day 1, day 3 and day 7. Pre-specified subgroup analyses include sepsis versus non-sepsis, surgical versus medical admissions, and active malignancy.

Primary Outcome Measure

Discriminative performance of admission plasma H3.1 for early clinical deterioration [ Time Frame: From ICU admission to 72 hours ]

Central Contacts

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