[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459519":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":50,"studyPopulation":47,"armGroups":51,"interventions":62,"overallOfficials":47,"centralContacts":68,"locations":74,"responsibleParty":141,"collaborators":143,"id":150,"slug":47,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":47,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":47,"overallStatus":77,"whyStopped":47,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with continued NCSE on EEG after 24 h (\"treatment failure\")","NCSE diagnosed using EEG and defined by the \"Salzburg criteria\" for NCSE (e.g. Leitinger et al. Lancet Neurology, 2016)","24 hours after randomisation",[14,18],{"measure":15,"description":16,"timeFrame":17},"Number of treatment related complications","e.g. tracheostoma, infections","at discharge, on average after 7 days",{"measure":19,"description":20,"timeFrame":17},"New neurological deficit","Neurological deficits are quantified using National Institute of Health Stroke Scale (NIHSS, maximum possible score is 42, the minimum score - indicating no deficits - is 0) at admission and discharge. New neurological deficit is defined as increase of NIHSS \\>5 at discharge",[22,25,28,32,35,39],{"measure":23,"description":24,"timeFrame":17},"Influence of cEEG on new neurological deficit","Patients receive either cEEG or spot EEG depending on the center. In this pre-specified analyses, the impact of cEEG vs. spot-EEG on the degree of new neurological deficits (outcome 3) will be compared",{"measure":26,"description":27,"timeFrame":17},"Duration of intensive care treatment","Definition: Time from intubation to discharge from ICU",{"measure":29,"description":30,"timeFrame":31},"Duration of hospitalization","Time from randomization to discharge from hospital in charge for acute treatment of NCSE","1-100 days, on average 7 days",{"measure":33,"description":34,"timeFrame":17},"Proportion of patients with superrefractory status epilepticus","Proportion of patients that develop superrefractory status epilepticus after randomization but during current hospitalization",{"measure":36,"description":37,"timeFrame":38},"Survival after discharge","Determined at ambulatory control 3,6,12 and 24 months after randomization","3, 6, 12, and 24 months after randomization",{"measure":40,"description":41,"timeFrame":38},"Quality of life after discharge","Determined using questionnaire\u002Fpatient survey (Quality of Life in Epilepsy Inventory, Qolie-31 Danish translation), at ambulatory controls 3, 6, 12, and 24 months after randomization",{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":47,"timePerspective":47,"maskingInfo":48},"RANDOMIZED","PARALLEL","Comparison of two treatment strategies","TREATMENT",null,{"masking":49,"maskingDescription":47,"whoMasked":47},"NONE","Persistent epileptic seizures, aka. status epilepticus (SE), are the second most common neurological cause of acute admissions. Around halv of the patients suffers from SE without prominent visible seizures (\"convulsions\"), which is referred to as non-convulsive status epilepticus (NCSE) and is afflicted with a long-term mortality of \\>50% also in patients without concomittant acute brain disease. There are no evidence-based treatment guidelines for NCSE but patients usually receive treatment with benzodiazepines followed by i.v. anti-seizure medication. If seizures continues, further treatment is controversial. The participating centers have long-standing experience in treating NCSE but use different, internationally accepted treatment strategies. Some initiate aggressive treatment with fast sedation at intensive care aiming at immediate seizure control, other estimate that the side effects of sediation does not outweigh the potential benefit and try high-dose i.v. anti-seizure medication that only slightly impair conciousness - often with success.\n\nThis randomized, open label, multicenter trial (Eudract 2021-003392-34) aims at clarifying the treatment of patients with NSCE not responding to standard therapy. Patients with verified NCSE based on clinical parameter or using electroencephalography (EEG) are randomized into a fast acute sedation group and a group that receives at least one additional, high-dose anti-seizure mediciation.\n\nPrimary objective endpoint is treatment failure 24 h after randomization as determined by EEG. Secondary endpoints are e.g. seizure-induced neurological damage, treatment-related complications and neurological long-term outcome.\n\nThe statistical planing aims at showing superiority of aggressive treatment, 140 patients shall be included in a three years period at the University Hospitals in Aarhus, Odense, Roskilde and Copenhagen.",[52,56],{"label":53,"type":54,"description":55,"interventionNames":47},"\"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).",{"label":57,"type":58,"description":59,"interventionNames":60},"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.",[61],"Drug: Rapid sedation",[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":47},"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.",[57],[69],{"name":70,"role":71,"phone":72,"phoneExt":47,"email":73},"Christoph P. Beier, M.D.","CONTACT","+4565411943","cbeier@health.sdu.dk",[75,91,103,117,129],{"facility":76,"status":77,"city":78,"state":47,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Aarhus Universitetshospital","RECRUITING","Aarhus","8200","Denmark","DK",{"type":83,"coordinates":84},"Point",[85,86],10.21076,56.15674,{"lat":86,"lon":85},[89],{"name":90,"role":71,"phone":47,"phoneExt":47,"email":47},"Jakob Christensen, M.D., Ph.d.",{"facility":92,"status":77,"city":93,"state":47,"zip":94,"country":80,"countryCode":81,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Rigshospitalet","Copenhagen","2100",{"type":83,"coordinates":96},[97,98],12.56553,55.67594,{"lat":98,"lon":97},[101],{"name":102,"role":71,"phone":47,"phoneExt":47,"email":47},"Anette S. Sidaros, M.D., Ph.d.",{"facility":104,"status":77,"city":105,"state":47,"zip":106,"country":80,"countryCode":81,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Department of Neurology","Herlev","2730",{"type":83,"coordinates":108},[109,110],12.43998,55.72366,{"lat":110,"lon":109},[113],{"name":114,"role":71,"phone":115,"phoneExt":47,"email":116},"Anders Hougaard, M.D.","+45 38 68 38 68","anders.hougaard@regionh.dk",{"facility":118,"status":77,"city":119,"state":47,"zip":120,"country":80,"countryCode":81,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Odense University Hospital","Odense","5000",{"type":83,"coordinates":122},[123,124],10.38831,55.39594,{"lat":124,"lon":123},[127],{"name":128,"role":71,"phone":47,"phoneExt":47,"email":73},"Christoph Beier, M.D.",{"facility":130,"status":77,"city":131,"state":47,"zip":132,"country":80,"countryCode":81,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"University Hospital of Zealand","Roskilde","4000",{"type":83,"coordinates":134},[135,136],12.08035,55.64152,{"lat":136,"lon":135},[139],{"name":140,"role":71,"phone":47,"phoneExt":47,"email":47},"Henning P. Hansen, M.D. Ph.D.",{"type":142,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[144,146,148],{"name":145,"class":6},"Aarhus University Hospital",{"name":130,"class":147},"UNKNOWN",{"name":149,"class":6},"Copenhagen University Hospital, Denmark","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":160,"type":161},140,"ESTIMATED","INTERVENTIONAL",[164],"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.",[167],"Non-Convulsive Status Epilepticus","2026-05-01",{"date":170,"type":171},"2026-05-04","ACTUAL",{"date":173,"type":171},"2022-02-07",{"date":175,"type":161},"2028-12-31",{"name":5,"class":6},5]