Status:
NOT_YET_RECRUITING
Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients
Lead Sponsor:
Erasme University Hospital
Conditions:
Sepsis
Septic Shock
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
The NuROPI study is a prospective, observational, non-interventional, monocentric study conducted in the Intensive Care Unit (ICU) of Erasme Hospital, Brussels. It aims to evaluate the association bet...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT07184593
Start Date
October 1 2025
End Date
September 30 2027
Last Update
September 22 2025
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