[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497390":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":41,"locations":46,"responsibleParty":172,"collaborators":174,"id":195,"slug":10,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":196,"sex":202,"minAge":203,"maxAge":10,"enrollmentInfo":204,"targetDuration":10,"studyType":207,"phases":10,"briefSummary":208,"conditions":209,"keywords":212,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"University of Milano Bicocca","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dual anti-glutamate therapy (DUAL)",null,"Patients who received ketamine as a continuous i.v. for 3 days (induction dose 1.5-3 mg\u002Fkg, followed by maintenance dose 2-10 mg\u002Fkg\u002Fh; dose adjustment according to EEG target of \"ketamine pattern\") + oral perampanel via nasogastric tube for 5 days (12 mg if weight \\> 60 kg; 9 mg if weight 50-60 kg; 6 mg if weight \\\u003C 50 kg), followed by gradual dose reduction according to clinical evolution.",[13],"Drug: Ketamine",{"label":15,"type":10,"description":16,"interventionNames":17},"Control (OTHERS)","Patients who received any antiseizure and anesthetic therapy according to usual clinical practice, excluding the two anti-glutamate drugs ketamine and perampanel.",[18],"Drug: Any anti-epileptic and anesthetic therapy, excluding Ketamine and Perampanel",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ketamine","\"Dual anti-glutamatergic therapy\" (DUAL) intervention group: patients who received ketamine as a continuous i.v. for 3 days (induction dose 1.5-3 mg\u002Fkg, followed by maintenance dose 2-10 mg\u002Fkg\u002Fh; dose adjustment according to EEG target of \"ketamine pattern\") + oral perampanel via nasogastric tube for 5 days (12 mg if weight \\> 60 kg; 9 mg if weight 50-60 kg; 6 mg if weight \\\u003C 50 kg), followed by gradual reduction according to clinical evolution.",[9],[26],"Perampanel",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Any anti-epileptic and anesthetic therapy, excluding Ketamine and Perampanel","Any antiseizure and anesthetic therapy according to usual clinical practice, excluding the two anti-glutamate drugs Ketamine and Perampanel",[15],[32],"Levetiracetam, Valproate, Phenytoin, Lacosamide, Topiramate, Propofol, Midazolam, Thiopental",[34,37],{"name":35,"affiliation":5,"role":36},"Simone Beretta, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":40},"Matteo Pozzi, MD","Fondazione IRCCS Gerardo dei Tintori Monza","STUDY_CHAIR",[42],{"name":35,"role":43,"phone":44,"phoneExt":10,"email":45},"CONTACT","00390392333568","simone.beretta@unimib.it",[47,62,75,87,99,111,124,136,148,160],{"facility":48,"status":49,"city":50,"state":51,"zip":10,"country":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"ASST Spedali Civili Brescia","RECRUITING","Brescia","BS","Italy",{"type":54,"coordinates":55},"Point",[56,57],10.21472,45.53558,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":10,"phoneExt":10,"email":10},"Laura Broglio",{"facility":63,"status":64,"city":65,"state":66,"zip":10,"country":52,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Ospedale Centrale di Bolzano","NOT_YET_RECRUITING","Bolzano","BZ",{"type":54,"coordinates":68},[69,70],11.33982,46.49067,{"lat":70,"lon":69},[73],{"name":74,"role":43,"phone":10,"phoneExt":10,"email":10},"Igor Florio",{"facility":76,"status":64,"city":77,"state":78,"zip":10,"country":52,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Ospedale G. Brotzu","Cagliari","CA",{"type":54,"coordinates":80},[81,82],9.11917,39.23054,{"lat":82,"lon":81},[85],{"name":86,"role":43,"phone":10,"phoneExt":10,"email":10},"Marta Corona, MD",{"facility":88,"status":64,"city":89,"state":90,"zip":10,"country":52,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Ospedale M. Bufalini","Cesena","FC",{"type":54,"coordinates":92},[93,94],12.24315,44.1391,{"lat":94,"lon":93},[97],{"name":98,"role":43,"phone":10,"phoneExt":10,"email":10},"Marco Longoni, MD",{"facility":100,"status":64,"city":101,"state":102,"zip":10,"country":52,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"AOU Careggi","Florence","FI",{"type":54,"coordinates":104},[105,106],11.24626,43.77925,{"lat":106,"lon":105},[109],{"name":110,"role":43,"phone":10,"phoneExt":10,"email":10},"Antonello Grippo, MD",{"facility":112,"status":49,"city":113,"state":114,"zip":115,"country":52,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Fondazione IRCCS San Gerardo dei Tintori Monza","Monza","MB","20900",{"type":54,"coordinates":117},[118,119],9.27246,45.58005,{"lat":119,"lon":118},[122],{"name":35,"role":43,"phone":123,"phoneExt":10,"email":45},"+390392333568",{"facility":125,"status":64,"city":126,"state":127,"zip":10,"country":52,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Azienda Ospedaliero-Universitaria di Modena","Modena","MO",{"type":54,"coordinates":129},[130,131],10.92539,44.64783,{"lat":131,"lon":130},[134],{"name":135,"role":43,"phone":10,"phoneExt":10,"email":10},"Stefano Meletti, MD, PhD",{"facility":137,"status":64,"city":138,"state":139,"zip":10,"country":52,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Azienda Ospedaliero-Universitaria di Parma","Parma","PR",{"type":54,"coordinates":141},[142,143],10.32618,44.79935,{"lat":143,"lon":142},[146],{"name":147,"role":43,"phone":10,"phoneExt":10,"email":10},"Lucia Zinno",{"facility":149,"status":49,"city":150,"state":151,"zip":10,"country":52,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Ospedale Santa Chiara Trento","Trento","TN",{"type":54,"coordinates":153},[154,155],11.12108,46.06787,{"lat":155,"lon":154},[158],{"name":159,"role":43,"phone":10,"phoneExt":10,"email":10},"Stefania Filipponi, MD",{"facility":161,"status":64,"city":162,"state":163,"zip":10,"country":52,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Azienda Ospedaliero-Universitaria Integrata di Verona","Verona","VR",{"type":54,"coordinates":165},[166,167],10.9938,45.43854,{"lat":167,"lon":166},[170],{"name":171,"role":43,"phone":10,"phoneExt":10,"email":10},"Marilena Casartelli, MD",{"type":173,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[175,177,178,180,182,184,186,187,189,191,193],{"name":176,"class":6},"Azienda Ospedaliera San Gerardo di Monza",{"name":125,"class":6},{"name":179,"class":6},"Azienda Ospedaliera Universitaria Integrata Verona",{"name":181,"class":6},"Ospedale Centrale Bolzano",{"name":183,"class":6},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia",{"name":185,"class":6},"Azienda Ospedaliero-Universitaria Careggi",{"name":137,"class":6},{"name":188,"class":6},"Santa Chiara Hospital",{"name":190,"class":6},"Ospedale M. Bufalini Cesena",{"name":192,"class":6},"Azienda Ospedaliera Brotzu",{"name":194,"class":6},"Istituto Di Ricerche Farmacologiche Mario Negri","100497390",false,"NCT05756621","Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest","SUPER-refractory Status Epilepticus After Cardiac Arrest: a Multicenter, Retrospective, Cohort Study of Dual Anti-glutamate Therapy With Ketamine and Perampanel","SUPER-CAT","Inclusion Criteria:\n\n* age ≥ 18 years\n* patients in coma after cardio-circulatory arrest (CCA) admitted to the Intensive Care Unit and treated with target temperature management (TTM) for the first 24 hours\n* initiation of continuous electroencephalographic (cEEG) monitoring within 24-36 hours of CCA\n* diagnosis of super-refractory status epilepticus, relapsed after the first cycle of anesthetics (lasting \\> 24 hours) and antiepileptic therapy, defined according to the international Salzburg criteria9\n* presence of pupillary reflex present bilaterally\n* presence of N20 cortical response present bilaterally\n\nExclusion Criteria:\n\n* EEG with periodic pattern (generalized periodic discharges; GPDs)\n* status epilepticus resolved after the first cycle of anesthetics + antiepileptics\n* pregnant women","ALL","18 Years",{"count":205,"type":206},80,"ESTIMATED","OBSERVATIONAL","Status epilepticus (SE) is found in 20-30% of patients in coma after cardiac arrest, is often refractory to medical therapy and is considered a negative prognostic factor. Intensity and duration of treatment of refractory and super-refractory post-anoxic SE pose the ethical dilemma between futility of treatments and, conversely, their premature suspension. A recent study by the Epilepsy Center of the San Gerardo Hospital has shown that patients with super-refractory post-anoxic SE and favorable prognostic indicators can achieve a good functional outcome in more than 40% of cases, if treated with intensive and protracted therapy.\n\nHowever, there is profound uncertainty about the best combination of antiseizure medications and anesthetics to use in this condition. A combined anti-glutamatergic therapy with ketamine (anti-NMDA receptor) and perampanel (anti-AMPA receptor), aimed at counteracting the excitotoxicity linked to global cerebral ischemia, could be particularly effective in the treatment of super-refractory SE with post-anoxic etiology. Preliminary results in the first 26 patients treated in the Coordinating Center of the project indicate that this therapy appears safe and highly effective (80% SE resolution, 40% good neurological outcome).\n\nThe aim of the SUPER-CAT study is to investigate the efficacy and safety of combined therapy with ketamine and perampanel (dual anti-glutamatergic therapy) in patients with post-anoxic super-refractory status epilepticus, compared to other therapies, using a multi-centre, retrospective, cohort study design.",[210,211],"Status Epilepticus","Cardiac Arrest",[213,214,215,216],"super-refractory","prognostic indicators","perampanel","ketamine","2025-07-24",{"date":219,"type":220},"2025-07-29","ACTUAL",{"date":222,"type":220},"2022-01-15",{"date":224,"type":206},"2025-09-30",{"name":5,"class":6},10]