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.
Admission to the intensive care unit (ICU) within the past 24 hours.
Patient who has expressed opposition to participate.
Age younger than 18 years.
Imminent death with an expected survival of less than 24 hours.
Presence of therapeutic limitations (e.g., no indication for intubation).
The study population will consist of 130 adult critically ill patients admitted to the Intensive Care Unit (ICU) of Erasme Hospital. Eligible participants must be 18 years or older and admitted to the ICU within the past 24 hours. All patients must have arterial or central venous access for blood sampling. The population will include a diverse group of critically ill individuals representing various acute conditions commonly encountered in intensive care: Sepsis Septic shock Cardiogenic shock Severe trauma Acute brain injury Severe trauma Post-cardiac arrest shock Severe pancreatitis
Cohort
Prospective
Not listed
7
Trial groupsSee each trial group below.
Mortality D30
To evaluate the association between initial levels of H3.1 nucleosomes in whole blood and 30-day mortality in a cohort of critically ill patients.
Nucleosome measurement correlation between point-of-care and chemiluminescence immunoassays (ChLIA)
To assess the correlation between nucleosome levels measured in whole blood at the point of care and traditional chemiluminescence immunoassays performed on plasma.
Cerebrospinal fluid (CSF) nucleosome levels
Cerebrospinal fluid (CSF) nucleosome levels (in patients with invasive neuromonitoring), to explore their potential role as biomarkers in acute brain injury.
Prolonged organ failure
Defined as the need for organ support (e.g., mechanical ventilation, vasopressors, renal replacement therapy) persisting ≥7 consecutive days.
In-hospital mortality
All-cause mortality occurring during index hospitalization.
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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This trial is not recruiting at the moment. You can still explore other options:
