Clinical Trial

Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients

Study acronym: NuROPI
Not Yet Recruiting
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Summary
The goal of this observational study is to evaluate whether whole blood H3.1 nucleosome levels can predict 30-day mortality in adult critically ill patients admitted to the ICU with conditions such as sepsis, septic shock, cardiogenic shock, severe trauma, post-cardiac arrest, acute brain injury, or severe acute pancreatitis. The main questions it aims to answer are: Do initial whole blood H3.1 nucleosome levels predict 30-day mortality in critically ill patients? Are whole blood nucleosome measurements using a novel point-of-care device correlated with traditional plasma chemiluminescence immunoassays (ChLIA)? If there is a comparison group: Researchers will compare point-of-care whole blood nucleosome results with plasma ChLIA assays to see if the device provides reliable and feasible bedside measurements. Participants will: Provide blood samples at admission, 6h, Day 1, Day 3, and Day 7 for nucleosome analysis. Undergo point-of-care H3.1 nucleosome measurement and parallel plasma storage for ChLIA testing. (If applicable, in acute brain injury patients with external ventricular drains) provide daily cerebrospinal fluid samples until Day 5, only if otherwise discarded. Have standard ICU data (SOFA, SAPS II, etc.) collected as part of routine care.
Trial Details
NCT Number NCT07184593
Lead Sponsor Erasme University Hospital
Conditions Sepsis, Septic Shock, Cardiac Arrest (CA), Pancreatitis, Acute Brain Injury, Trauma Blunt, Cardiogenic Shock
Enrollment 130 participants
Start Date 2025-10-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-22