[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607133":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":30,"locations":10,"responsibleParty":36,"collaborators":10,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":10,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":62,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":10},{"fullName":5,"class":6},"Erasme University Hospital","OTHER",[8,12,15,18,21,24,27],{"label":9,"type":10,"description":11,"interventionNames":10},"Sepsis",null,"As defined by sepsis-3 definition (excluding septic shock, around 30 patients)",{"label":13,"type":10,"description":14,"interventionNames":10},"Septic shock","as defined per SEPSIS-3 definition (around 30 patients)",{"label":16,"type":10,"description":17,"interventionNames":10},"Cardiogenic shock","classified as at least SCAI stage C (approximately 10 patients)",{"label":19,"type":10,"description":20,"interventionNames":10},"Severe trauma","Requiring at least 4 units of red blood cells within 6 hours post-admission (approximately 10 patients)",{"label":22,"type":10,"description":23,"interventionNames":10},"Acute brain injury","requiring invasive neuromonitoring (approximately 20 patients)",{"label":25,"type":10,"description":26,"interventionNames":10},"Post-cardiac arrest","With at least 15 minutes of no or low perfusion (intra or extra hospital setting) (approximately 20 patients)",{"label":28,"type":10,"description":29,"interventionNames":10},"Severe acute pancreatitis","requiring ICU management (approximately 10 patients)",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Charls Dehout, M.D","CONTACT","+32 2 555 6589","charles.dehout@hubruxelles.be",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Charles Dehout","Attending physician, PhD student","100607133","nucleosome-monitoring-relevance-for-outcome-prediction-in-critically-ill-patients-100607133",false,"NCT07184593","Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients","Validation of a Point-of-care Device for Rapid Bedside Measurement of Circulating Nucleosome Levels in Critically Ill Patients and Study of Its Relevance to Prognostication","NuROPI","Inclusion Criteria:\n\n* Admission to the intensive care unit (ICU) within the past 24 hours.\n* Patient must meet one of the following conditions:\n\nSepsis, defined according to SEPSIS-3 criteria.\n\nSeptic shock, defined according to SEPSIS-3 criteria.\n\nCardiogenic shock, classified as Stage C according to the Society for Cardiovascular Angiography and Interventions (SCAI).\n\nSevere trauma requiring transfusion of four or more units of red blood cells within six hours.\n\nAcute brain injury requiring invasive neuromonitoring.\n\nPost-cardiac arrest with at least 15 minutes of no or low perfusion.\n\nSevere acute pancreatitis requiring ICU-level care.\n\n\\- Presence of an arterial or central venous catheter to allow blood sampling.\n\nExclusion Criteria\n\n* Patient who has expressed opposition to participate.\n* Age younger than 18 years.\n* Imminent death with an expected survival of less than 24 hours.\n* Presence of therapeutic limitations (e.g., no indication for intubation).\n* Active cancer.\n* Absence of the required vascular access.\n* ICU admission longer than 24 hours prior to screening.\n* Readmission of a previously enrolled patient.","ALL","18 Years",{"count":51,"type":52},130,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main questions it aims to answer are:\n\nDo initial whole blood H3.1 nucleosome levels predict 30-day mortality in critically ill patients?\n\nAre whole blood nucleosome measurements using a novel point-of-care device correlated with traditional plasma chemiluminescence immunoassays (ChLIA)?\n\nIf 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.\n\nParticipants will:\n\nProvide blood samples at admission, 6h, Day 1, Day 3, and Day 7 for nucleosome analysis.\n\nUndergo point-of-care H3.1 nucleosome measurement and parallel plasma storage for ChLIA testing.\n\n(If applicable, in acute brain injury patients with external ventricular drains) provide daily cerebrospinal fluid samples until Day 5, only if otherwise discarded.\n\nHave standard ICU data (SOFA, SAPS II, etc.) collected as part of routine care.",[9,56,57,58,59,60,61],"Septic Shock","Cardiac Arrest (CA)","Pancreatitis","Acute Brain Injury","Trauma Blunt","Cardiogenic Shock",[63,64,65,66,16,67,22],"nucleosome","septic shock","Histones","Cardiac Arrest","Trauma","NOT_YET_RECRUITING","2025-09-17",{"date":71,"type":72},"2025-09-22","ACTUAL",{"date":74,"type":52},"2025-10-01",{"date":76,"type":52},"2027-09-30",{"name":5,"class":6}]