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Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients

NCT07184593 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2025-09-22

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Septic Shock
  • Cardiac Arrest (CA)
  • Pancreatitis
  • Acute Brain Injury
  • Trauma Blunt
  • Cardiogenic Shock

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-09-30
Completion
2027-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07184593 on ClinicalTrials.gov