[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459519":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":25,"locations":31,"responsibleParty":98,"collaborators":100,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":12,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":12,"overallStatus":34,"whyStopped":12,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"\"Non-sedative medical treatment\"","NO_INTERVENTION","The patient is treated with an additional high-dose intravenous antiepileptic drug, which is selected by the treating neurologist. If NCSE continues to be detected at cEEG or clinically\\> 3 hours after starting treatment, the patient should receive standard treatment (i.e. sedation in the intensive care unit or addition of additional intravenous antiepileptic drugs) in accordance with local guidelines and the assessment of the treating neurologist. The following preparations are permitted as additional treatment:\n\nLevetiracetam (60 mg \u002F kg as saturation dose followed by maintenance dose of 2-4 g \u002F day), valproate (60 mg \u002F kg as saturation dose followed by maintenance dose of 20 mg \u002F kg \u002F day), phosphenytoin (20 PE as saturation dose followed by maintenance dose 5 mg PE \u002F kg \u002F day), lacosamide (400 mg as a saturation dose followed by a maintenance dose of 200-400 mg \u002F day), topiramate (200-400 mg per probe as a saturation dose followed by a maintenance dose of 200-400 mg \u002F day).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Fast sedation","EXPERIMENTAL","Within a maximum of 60 minutes after the diagnosis of NCSE (EEG or clinical), the patient must be sedated with high-dose Propofol (bolus 3-5 g \u002F kg, maintenance dose 5-10 mg \u002F kg \u002F hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg \u002F kg \u002F h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone. After 20 hours, the sedation should be completely phased out within 3 hours.",[18],"Drug: Rapid sedation",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","Rapid sedation","High-dose Propofol (bolus 3-5 g \u002F kg, maintenance dose 5-10 mg \u002F kg \u002F hour) to - 5 on the Richmond agitation sedation scale (RASS) for 20 hours, and a single anti-epileptic drug should be added as adjunctive therapy. Addition of low-dose Midazolam (max. 0.1 mg \u002F kg \u002F h) is permitted if deep sedation (defined clinically by RASS -5) is not possible with Propofol alone.",[14],[26],{"name":27,"role":28,"phone":29,"phoneExt":12,"email":30},"Christoph P. Beier, M.D.","CONTACT","+4565411943","cbeier@health.sdu.dk",[32,48,60,74,86],{"facility":33,"status":34,"city":35,"state":12,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Aarhus Universitetshospital","RECRUITING","Aarhus","8200","Denmark","DK",{"type":40,"coordinates":41},"Point",[42,43],10.21076,56.15674,{"lat":43,"lon":42},[46],{"name":47,"role":28,"phone":12,"phoneExt":12,"email":12},"Jakob Christensen, M.D., Ph.d.",{"facility":49,"status":34,"city":50,"state":12,"zip":51,"country":37,"countryCode":38,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Rigshospitalet","Copenhagen","2100",{"type":40,"coordinates":53},[54,55],12.56553,55.67594,{"lat":55,"lon":54},[58],{"name":59,"role":28,"phone":12,"phoneExt":12,"email":12},"Anette S. Sidaros, M.D., Ph.d.",{"facility":61,"status":34,"city":62,"state":12,"zip":63,"country":37,"countryCode":38,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Department of Neurology","Herlev","2730",{"type":40,"coordinates":65},[66,67],12.43998,55.72366,{"lat":67,"lon":66},[70],{"name":71,"role":28,"phone":72,"phoneExt":12,"email":73},"Anders Hougaard, M.D.","+45 38 68 38 68","anders.hougaard@regionh.dk",{"facility":75,"status":34,"city":76,"state":12,"zip":77,"country":37,"countryCode":38,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Odense University Hospital","Odense","5000",{"type":40,"coordinates":79},[80,81],10.38831,55.39594,{"lat":81,"lon":80},[84],{"name":85,"role":28,"phone":12,"phoneExt":12,"email":30},"Christoph Beier, M.D.",{"facility":87,"status":34,"city":88,"state":12,"zip":89,"country":37,"countryCode":38,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University Hospital of Zealand","Roskilde","4000",{"type":40,"coordinates":91},[92,93],12.08035,55.64152,{"lat":93,"lon":92},[96],{"name":97,"role":28,"phone":12,"phoneExt":12,"email":12},"Henning P. Hansen, M.D. Ph.D.",{"type":99,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[101,103,105],{"name":102,"class":6},"Aarhus University Hospital",{"name":87,"class":104},"UNKNOWN",{"name":106,"class":6},"Copenhagen University Hospital, Denmark","100459519","phase-3-fast-acute-sedation-at-intensive-care-vs-high-dose-iv-anti-seizure-medication-for-treatment-of-non-convulsive-status-epilepticus-fast-trial-100459519",false,"NCT05263674","Fast Acute Sedation at Intensive Care vs. High-dose i.v. Anti-seizure Medication for Treatment of Non-convulsive Status Epilepticus (FAST-trial)","FAST","Inclusion Criteria:\n\n* Adult patients (older than 18 years) with EEG-verified NCSE, according to the Salzburg criteria, who have not responded to appropriate treatment with benzodiazepines and at least one 2nd line i.v. anti-seizure medication according to the current Danish national neurological treatment guidelines (Levetiracetam, Fosfenytoin or Valproate).\n\nExclusion Criteria:\n\n* patients with epilepticus status due to acute neuroinfection (e.g. bacterial meningitis or viral encephalitis)\n* acute traumatic or spontaneous intracranial hemorrhage\n* suspicion of cerebral anoxia \u002F hypoxia \u002F hypoglycemia \u002F epileptic encephalopathy\n* contraindications to anti-seizure medication defined in the protocol\n* contraindications to anesthesia treatment in intensive care\n* focal motor status epilepticus without relevant conscious influence (Glasgow Coma Scale\\> 13)\n* known epileptic encephalopathy\n* Clinical need for acute intubation","ALL","18 Years","120 Years",{"count":118,"type":119},140,"ESTIMATED","INTERVENTIONAL",[122],"PHASE3","This open-label, randomized multicenter trial aims at clarifying the standard of care of patients with non-convulsive status epilepticus not responding to treatment with benzodiazepines and at least one high-dose intra venous anti-seizure medication.",[125],"Non-Convulsive Status Epilepticus","2026-05-01",{"date":128,"type":129},"2026-05-04","ACTUAL",{"date":131,"type":129},"2022-02-07",{"date":133,"type":119},"2028-12-31",{"name":5,"class":6},5]