[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587007":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":59,"collaborators":20,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":20,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hemadsorption","EXPERIMENTAL","Hemadsorption via a dialysis catheter will be performed in patients who are unconscious due to an intoxication with quantifiable benzodiazepines or tricyclic antidepressants 8 hours after admission. Before and after application fo this hemadsorption filter plasma titers of this drug will be obtained. After application of the hemadsorption filter pre- and post-filter titers will be obtained.",[13],"Device: Hemadsorption filter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Hemadsorption filter","Plasma titers neurodepressing drug:\n\n* At admission to the hospital (standard of care)\n* 2 hours after admission (+\u002F- 15 minutes)\n* 4 hours after admission (+\u002F- 15 minutes)\n* 6 hours after admission (+\u002F- 15 minutes)\n* 8 hours after admission (+\u002F- 15 minutes)\n* Just before start hemadsorption\n\nHemadsorption via dialysis catheter in patients still fulfilling inclusion criteria 8 hours after admission.\n\nSubsequent plasma titers pre- and post-hemadosorption filter:\n\n* 15 minutes after start of hemadsorption (+ 15 minutes)\n* 4 hours after start of hemadsorption (+\u002F- 15 minutes)\n* 8 hours after start of hemadsorption (+\u002F- 15 minutes)\n* 12 hours after start of hemadsorption (+\u002F- 15 minutes)\n* 16 hours after start of hemadsorption (+\u002F- 15 minutes)\n* 20 hours after start of hemadsorption (+\u002F- 15 minutes)\n* 24 hours after start of hemadsorption (+\u002F- 15 minutes)\n* Every other 24 hours until cessation of hemadsorption or normalization of the plasma titer (+\u002F- 15 minutes)",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Michaël Mekeirele, Medical Doctor","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Marie-Claire vanmalderen, Study coordinator","CONTACT","0032 24 76 31 10","Marieclaire.vanmalderen@uzbrussel.be",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Merel Stevens, Study coordinator","0032 24 76 30 96","Merel.stevens@uzbrussel.be",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Brussels","Brussels Capital","1090","Belgium","BE",{"type":44,"coordinates":45},"Point",[46,47],4.34878,50.85045,{"lat":47,"lon":46},[50,54,58],{"name":51,"role":28,"phone":52,"phoneExt":20,"email":53},"Marie-Claire Van Malderen, Study nurse","00324763110","marie-claire.vanmalderen@uzbrussel.be",{"name":55,"role":28,"phone":56,"phoneExt":20,"email":57},"Merel Stevens, Study Nurse","00324763096","merel.stevens@uzbrussel.be",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Michaël Mekeirele","Medical Doctor, Principal Investigator","100587007","hemadsorption-to-enhance-drug-elimination-in-intoxications-100587007",false,"NCT06922786","Hemadsorption to Enhance Drug Elimination in Intoxications","MATRIX","Inclusion Criteria:\n\n1. older than18 years\n2. Admission to ICU\n3. GCS \\\u003C 8 or requiring Flumazenil 8 hours after hospital admission\n4. Having an intoxication with a benzodiazepine or tricyclic antidepressant that we can measure\u002Fquantify\n5. Having a risk factor for delayed drug elimination defined as either Cirrhosis CHILD B\u002FC or chronic kidney insufficiency KDIGO 3b or worse\n\nExclusion Criteria:\n\n1. Pregnant patient\n2. Patients in chronic dialysis before admission\n3. Need for mechanical ventilation for other reasons than intoxications (e.g. pneumonia, neurotrauma)\n4. Concomitant pathology requiring continued intravenous sedation\n5. Known history of seizures\n6. Contra-indication to heparin use\n7. DNR restricting the use of mechanical ventilation or dialysis","ALL","18 Years",{"count":72,"type":73},18,"ESTIMATED","INTERVENTIONAL",[76],"NA","In this trial the investigators assess the effectiveness of applying a hemadsorber (cytosorb®) in removing benzodiazepines or tricyclic antidepressants in intoxicated patients admitted to ICU with prolonged impaired consciousness. This is a one arm interventional investigation where a hemadsorption filter is applied in patients fulfilling inclusion criteria 8 hours after admission. Plasma titer of the neurodepressing drug will be collected sequentially both before and after start of hemadsorption to evaluate the speed of drug elimination before and after application of a hemadsorption filter. Pre- and post filter titers will be obtained to evaluate adsorbability and to evaluate time to saturation of the filter.",[79],"Intoxication by Drug",[81,82,83,9],"Benzodiazepine","Tricyclic antidepressant","Intoxication","2025-05-12",{"date":86,"type":87},"2025-05-15","ACTUAL",{"date":89,"type":73},"2025-05",{"date":91,"type":73},"2029-01",{"name":5,"class":6},1]