PMID- 38178048 OWN - NLM STAT- MEDLINE DCOM- 20240108 LR - 20240108 IS - 1471-2377 (Electronic) IS - 1471-2377 (Linking) VI - 24 IP - 1 DP - 2024 Jan 4 TI - Sustained effort network for treatment of status epilepticus/European academy of neurology registry on adult refractory status epilepticus (SENSE-II/AROUSE). PG - 19 LID - 10.1186/s12883-023-03505-y [doi] LID - 19 AB - BACKGROUND: Status Epilepticus (SE) is a common neurological emergency associated with a high rate of functional decline and mortality. Large randomized trials have addressed the early phases of treatment for convulsive SE. However, evidence regarding third-line anesthetic treatment and the treatment of nonconvulsive status epilepticus (NCSE) is scarce. One trial addressing management of refractory SE with deep general anesthesia was terminated early due to insufficient recruitment. Multicenter prospective registries, including the Sustained Effort Network for treatment of Status Epilepticus (SENSE), have shed some light on these questions, but many answers are still lacking, such as the influence exerted by distinct EEG patterns in NCSE on the outcome. We therefore initiated a new prospective multicenter observational registry to collect clinical and EEG data that combined may further help in clinical decision-making and defining SE. METHODS: Sustained effort network for treatment of status epilepticus/European Academy of Neurology Registry on refractory Status Epilepticus (SENSE-II/AROUSE) is a prospective, multicenter registry for patients treated for SE. The primary objectives are to document patient and SE characteristics, treatment modalities, EEG, neuroimaging data, and outcome of consecutive adults admitted for SE treatment in each of the participating centers and to identify factors associated with outcome and refractoriness. To reach sufficient statistical power for multivariate analysis, a cohort size of 3000 patients is targeted. DISCUSSION: The data collected for the registry will provide both valuable EEG data and information about specific treatment steps in different patient groups with SE. Eventually, the data will support clinical decision-making and may further guide the planning of clinical trials. Finally, it could help to redefine NCSE and its management. TRIAL REGISTRATION: NCT number: NCT05839418. CI - (c) 2024. The Author(s). FAU - Damien, Charlotte AU - Damien C AD - Department of Neurology, Hopital Universitaire de Bruxelles, Hopital Erasme, Brussels, Belgium. FAU - Leitinger, Markus AU - Leitinger M AD - Department of Neurology Neurointensive Care and Neurorehabilitation, Centre for Cognitive Neuroscience, Christian Doppler University Hospital, Paracelsus Medical University, European Reference Network EpiCARE, Salzburg, Austria. AD - Neuroscience Institute, Department of Neurology, Centre for Cognitive Neuroscience, Christian Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria. FAU - Kellinghaus, Christoph AU - Kellinghaus C AD - Epilepsy Center Munster-Osnabruck, Klinikum Osnabruck, Osnabruck, Germany. FAU - Strzelczyk, Adam AU - Strzelczyk A AD - Department of Neurology and Epilepsy Center Frankfurt Rhine-Main, Goethe-University and University Hospital Frankfurt, Frankfurt am Main, Germany. FAU - De Stefano, Pia AU - De Stefano P AD - EEG & Epilepsy Unit, Department of Clinical Neurosciences, University Hospital of Geneva, Geneva, Switzerland. AD - Neuro-Intensive Care Unit, Department of Intensive Care, University Hospital of Geneva, Geneva, Switzerland. FAU - Beier, Christoph P AU - Beier CP AD - Department of Neurology, Odense University Hospital, Odense, Denmark. FAU - Sutter, Raoul AU - Sutter R AD - Department of Neurology, University Hospital Basel, Basel, Switzerland. AD - Intensive Care Units, University Hospital Basel, Basel, Switzerland. FAU - Kamppi, Leena AU - Kamppi L AD - Department of Neurology, Epilepsia Helsinki, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. FAU - Strbian, Daniel AU - Strbian D AD - Department of Neurology, Epilepsia Helsinki, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. FAU - Tauboll, Erik AU - Tauboll E AD - Department of Neurology, Oslo University Hospital, Oslo, Norway. FAU - Rosenow, Felix AU - Rosenow F AD - Department of Neurology and Epilepsy Center Frankfurt Rhine-Main, Goethe-University and University Hospital Frankfurt, Frankfurt am Main, Germany. FAU - Helbok, Raimund AU - Helbok R AD - Department of Neurology, Johannes Kepler University Linz, Linz, Austria. FAU - Ruegg, Stephan AU - Ruegg S AD - Department of Neurology, Epilepsia Helsinki, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. FAU - Damian, Maxwell AU - Damian M AD - Department of Critical Care, Essex Cardiothoracic Centre, Basildon, UK. FAU - Trinka, Eugen AU - Trinka E AD - Department of Neurology Neurointensive Care and Neurorehabilitation, Centre for Cognitive Neuroscience, Christian Doppler University Hospital, Paracelsus Medical University, European Reference Network EpiCARE, Salzburg, Austria. AD - Neuroscience Institute, Department of Neurology, Centre for Cognitive Neuroscience, Christian Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria. AD - Karl Landsteiner Institute of Neurorehabilitation and Space Neurology, Salzburg, Austria. AD - Department of Public Health, Health Services Research and Health Technology Assessment, UMIT - University for Health Sciences, Medical Informatics and Technology, Hall en Tyrol, Austria. FAU - Gaspard, Nicolas AU - Gaspard N AD - Department of Neurology, Hopital Universitaire de Bruxelles, Hopital Erasme, Brussels, Belgium. Nicolas.Gaspard@hubruxelles.be. AD - Department of Neurology, Yale University School of Medicine, New Haven, CT, USA. Nicolas.Gaspard@hubruxelles.be. LA - eng SI - ClinicalTrials.gov/NCT05839418 GR - 320030_169379/Swiss National Foundation/ PT - Journal Article PT - Multicenter Study DEP - 20240104 PL - England TA - BMC Neurol JT - BMC neurology JID - 100968555 RN - 0 (Anticonvulsants) SB - IM MH - Adult MH - Humans MH - Prospective Studies MH - *Status Epilepticus/diagnosis/drug therapy MH - Multivariate Analysis MH - Registries MH - Electroencephalography MH - Anticonvulsants/therapeutic use PMC - PMC10765797 OTO - NOTNLM OT - Anti-seizure medication OT - Continuous intravenous anesthetic Drugs OT - EEG OT - Outcome OT - Refractoriness OT - Status Epilepticus COIS- Christoph Kellinghaus has received speaker's honoraria from Angelini Pharma, Eisai, Jazz Pharmaceuticals, UCB, LivaNova. He has served on advisory boards for Angelini Pharma, Eisai and Marinus Pharma. Adam Strzelczyk received personal fees and grants from Angelini Pharma, Biocodex, Desitin Arzneimittel, Eisai, Jazz (GW) Pharmaceuticals, Marinus Pharma, Precisis, Takeda, UCB (Zogenix) Pharma, and UNEEG medical. AS is editor-in-chied of Clinical Epileptology and editorial board member of Neurological Research and Practice. Raoul Sutter received research grants from the Swiss National Foundation (No 320030_169379), the Research Fund of the University Basel, the Scientific Society Basel, and the Gottfried Julia Bangerter-Rhyner Foundation. He received personal grants from UCB-pharma and holds stocks from Novartis, Roche, Alcon, and Johnson & Johnson. Leena Kamppi reports speaker's honoraria from UCB, Merck and Eisai and personal grants from Michael Foundation, Finnish Neurological Society, Finnish Cultural Foundation and HUS Neurocenter. Daniel Strbian serves in the advisory board for AstraZeneca, Alexion, Janssen, BMS, Orion, CLS Behring, Herantis Pharma and received unrestricted education grant from Boehringer Ingelheim. Stephan Ruegg has received honoraria from serving on the scientific advisory boards of Arvelle/Angelini, Bial, Eisai, GW, and UCB-pharma, and from serving as a consultant for Arvelle/Angelini, Eisai, Pfizer, Novartis, Sandoz, and UCB-pharma. He has received speaker's honoraria from Eisai and Novartis. He does not hold any stocks of any pharmaceutical industries or manufacturers of medical devices. He disclosed that he is co-editor-in-chief of Clinical Epileptology (01/01/2022; no payments). Eugen Trinka reports paid consultancy from Arvelle, Argenx, Angelini, Clexio, UCB, Eisai, Epilog, Bial, Medtronic, Everpharma, Biogen, Takeda, Jazz, Liva-Nova, Newbridge, Sunovion, GW Pharmaceuticals/Jazz, Marinus; Research funding (directly, or to institution) from GSK, Biogen, Eisai, Novartis, Red Bull, Bayer, and UCB; Speaker's honoraria from Arvelle, Angelini, GSK, GW Pharmaceuticals, Bohringer Ingelheim, Eisai, Epilog, Bial, Everpharma, UCB, Liva-Nova, Newbridge, Hikma, Novartis, and Sanofi. He is CEO of Neuroconsult Ges.m.b.H. Grants from Austrian Science Fund (FWF), Osterreichische Nationalbank, and the European Union. Nicolas Gaspard reports speaker's honoraria from UCB Pharma and Angelini Pharma; paid consultancy from UCB Pharma and Marinus and research funding (directly, or to institution) from UCB and Angelini; grants from Belgian National Research Fund; Fonds Erasme pour la Recherche Medicale and INNOVIRIS; honoraria from MedLink Neurology. Other authors declare that they have no competing interest. EDAT- 2024/01/05 00:42 MHDA- 2024/01/08 06:43 PMCR- 2024/01/04 CRDT- 2024/01/04 23:42 PHST- 2023/07/14 00:00 [received] PHST- 2023/12/11 00:00 [accepted] PHST- 2024/01/08 06:43 [medline] PHST- 2024/01/05 00:42 [pubmed] PHST- 2024/01/04 23:42 [entrez] PHST- 2024/01/04 00:00 [pmc-release] AID - 10.1186/s12883-023-03505-y [pii] AID - 3505 [pii] AID - 10.1186/s12883-023-03505-y [doi] PST - epublish SO - BMC Neurol. 2024 Jan 4;24(1):19. doi: 10.1186/s12883-023-03505-y.