Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasme University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Admission to the intensive care unit (ICU) within the past 24 hours.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

130 Participants
are grouped into 7 trial groups

7

Trial groups

See each trial group below.

Locations

This trial has no locations

Sponsors and collaborators