Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients (NCT07184593) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients
130 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Admission to the intensive care unit (ICU) within the past 24 hours.
* Patient must meet one of the following conditions:
Sepsis, defined according to SEPSIS-3 criteria.
Septic shock, defined according to SEPSIS-3 criteria.
Cardiogenic shock, classified as Stage C according to the Society for Cardiovascular Angiography and Interventions (SCAI).
Severe trauma requiring transfusion of four or more units of red blood cells within six hours.
Acute brain injury requiring invasive neuromonitoring.
Post-cardiac arrest with at least 15 minutes of no or low perfusion.
Severe acute pancreatitis requiring ICU-level care.
\- Presence of an arterial or central venous catheter to allow blood sampling.
Exclusion Criteria
* 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).
* Active cancer.
* Absence of the required vascular access.
* ICU admission longer than 24 hours prior to screening.
* Readmission of a previously enrolled patient.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.