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.
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
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
Consecutive adult patients admitted to the Intensive Care Unit (ICU) of Erasme Hospital (Hôpital Universitaire de Bruxelles, Brussels, Belgium), all admission diagnoses combined. To avoid over-representation of elective post-operative admissions, enrolment is capped at 20 neurosurgical and 50 cardiac-surgery patients.
Cohort
Prospective
Plasma H3.1 nucleosome measurement
Diagnostic testMeasurement 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.
Discriminative performance of admission plasma H3.1 for early clinical deterioration
Area under the receiver operating characteristic curve (AUROC) of plasma H3.1 measured at ICU admission, alone and combined with routine ICU parameters, for predicting clinical deterioration. Clinical deterioration is defined as an increase of at least 2 points in the Sequential Organ Failure Assessment version 2 (SOFA-2) score from admission, or ICU death, within 72 hours of ICU admission.
28-day all-cause mortality
Death from any cause within 28 days of ICU admission. Association with admission H3.1 will be assessed after adjustment for SOFA-2 and Simplified Acute Physiology Score II (SAPS II).
Change in SOFA-2 score at 72 hours
Difference between SOFA-2 score at 72 hours (D3) and SOFA-2 score at ICU admission (H0), analysed as a continuous variable and as an increase of at least 2 points. Assessed in patients still in the ICU at 72 hours.
Early ICU mortality
ICU death from any cause within 72 hours of the admission sample (H0).
ICU mortality
Death from any cause during the ICU stay
Progression to chronic kidney disease (CKD)
Defined as estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m² persisting for ≥3 months, or requirement for chronic dialysis.
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