[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497390":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":41,"locations":46,"responsibleParty":173,"collaborators":175,"id":196,"slug":197,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":198,"sex":204,"minAge":205,"maxAge":10,"enrollmentInfo":206,"targetDuration":10,"studyType":209,"phases":10,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},{"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",[47,63,76,88,100,112,125,137,149,161],{"facility":48,"status":49,"city":50,"state":51,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"ASST Spedali Civili Brescia","RECRUITING","Brescia","BS","Italy","IT",{"type":55,"coordinates":56},"Point",[57,58],10.21472,45.53558,{"lat":58,"lon":57},[61],{"name":62,"role":43,"phone":10,"phoneExt":10,"email":10},"Laura Broglio",{"facility":64,"status":65,"city":66,"state":67,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Ospedale Centrale di Bolzano","NOT_YET_RECRUITING","Bolzano","BZ",{"type":55,"coordinates":69},[70,71],11.33982,46.49067,{"lat":71,"lon":70},[74],{"name":75,"role":43,"phone":10,"phoneExt":10,"email":10},"Igor Florio",{"facility":77,"status":65,"city":78,"state":79,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Ospedale G. Brotzu","Cagliari","CA",{"type":55,"coordinates":81},[82,83],9.11917,39.23054,{"lat":83,"lon":82},[86],{"name":87,"role":43,"phone":10,"phoneExt":10,"email":10},"Marta Corona, MD",{"facility":89,"status":65,"city":90,"state":91,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Ospedale M. Bufalini","Cesena","FC",{"type":55,"coordinates":93},[94,95],12.24315,44.1391,{"lat":95,"lon":94},[98],{"name":99,"role":43,"phone":10,"phoneExt":10,"email":10},"Marco Longoni, MD",{"facility":101,"status":65,"city":102,"state":103,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"AOU Careggi","Florence","FI",{"type":55,"coordinates":105},[106,107],11.24626,43.77925,{"lat":107,"lon":106},[110],{"name":111,"role":43,"phone":10,"phoneExt":10,"email":10},"Antonello Grippo, MD",{"facility":113,"status":49,"city":114,"state":115,"zip":116,"country":52,"countryCode":53,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Fondazione IRCCS San Gerardo dei Tintori Monza","Monza","MB","20900",{"type":55,"coordinates":118},[119,120],9.27246,45.58005,{"lat":120,"lon":119},[123],{"name":35,"role":43,"phone":124,"phoneExt":10,"email":45},"+390392333568",{"facility":126,"status":65,"city":127,"state":128,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Azienda Ospedaliero-Universitaria di Modena","Modena","MO",{"type":55,"coordinates":130},[131,132],10.92539,44.64783,{"lat":132,"lon":131},[135],{"name":136,"role":43,"phone":10,"phoneExt":10,"email":10},"Stefano Meletti, MD, PhD",{"facility":138,"status":65,"city":139,"state":140,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Azienda Ospedaliero-Universitaria di Parma","Parma","PR",{"type":55,"coordinates":142},[143,144],10.32618,44.79935,{"lat":144,"lon":143},[147],{"name":148,"role":43,"phone":10,"phoneExt":10,"email":10},"Lucia Zinno",{"facility":150,"status":49,"city":151,"state":152,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Ospedale Santa Chiara Trento","Trento","TN",{"type":55,"coordinates":154},[155,156],11.12108,46.06787,{"lat":156,"lon":155},[159],{"name":160,"role":43,"phone":10,"phoneExt":10,"email":10},"Stefania Filipponi, MD",{"facility":162,"status":65,"city":163,"state":164,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Azienda Ospedaliero-Universitaria Integrata di Verona","Verona","VR",{"type":55,"coordinates":166},[167,168],10.9938,45.43854,{"lat":168,"lon":167},[171],{"name":172,"role":43,"phone":10,"phoneExt":10,"email":10},"Marilena Casartelli, MD",{"type":174,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[176,178,179,181,183,185,187,188,190,192,194],{"name":177,"class":6},"Azienda Ospedaliera San Gerardo di Monza",{"name":126,"class":6},{"name":180,"class":6},"Azienda Ospedaliera Universitaria Integrata Verona",{"name":182,"class":6},"Ospedale Centrale Bolzano",{"name":184,"class":6},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia",{"name":186,"class":6},"Azienda Ospedaliero-Universitaria Careggi",{"name":138,"class":6},{"name":189,"class":6},"Santa Chiara Hospital",{"name":191,"class":6},"Ospedale M. Bufalini Cesena",{"name":193,"class":6},"Azienda Ospedaliera Brotzu",{"name":195,"class":6},"Istituto Di Ricerche Farmacologiche Mario Negri","100497390","dual-anti-glutamate-therapy-in-super-refractory-status-epilepticus-after-cardiac-arrest-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":207,"type":208},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.",[212,213],"Status Epilepticus","Cardiac Arrest",[215,216,217,218],"super-refractory","prognostic indicators","perampanel","ketamine","2025-07-24",{"date":221,"type":222},"2025-07-29","ACTUAL",{"date":224,"type":222},"2022-01-15",{"date":226,"type":208},"2025-09-30",{"name":5,"class":6},10]