Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07184593 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients

Study acronym: NuROPI
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Sep 30, 2026 → Sep 30, 2028
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Erasme University Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Sep 30, 2026 to Sep 30, 2028 Show 10 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 130 → 1000 participants
    • Start date: Oct 1, 2025 to Oct 1, 2026
    • Study completion pushed from Sep 30, 2027 to Sep 30, 2028
    • Interventions modified
    • Trial arms changed: 7 → 1
    • Eligibility criteria shortened, about 57 words
    • Secondary endpoints: 4 to 16
    • Study description expanded, about 49 words
    • Publications: details revised at 11 of 11 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07184593
Lead Sponsor Erasme University Hospital
Conditions
(from sponsor)
Sepsis, Septic Shock, Cardiac Arrest (CA), Pancreatitis, Acute Brain Injury, Trauma Blunt, Cardiogenic Shock
Related terms Brain Injuries, Heart Arrest, Pancreatitis, Sepsis, Shock, Cardiogenic, Shock, Septic, Wounds and Injuries, Wounds, Nonpenetrating
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov