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Multicenter Study
. 2024 Jan 4;24(1):19.
doi: 10.1186/s12883-023-03505-y.

Sustained effort network for treatment of status epilepticus/European academy of neurology registry on adult refractory status epilepticus (SENSE-II/AROUSE)

Charlotte Damien  1 , Markus Leitinger  2   3 , Christoph Kellinghaus  4 , Adam Strzelczyk  5 , Pia De Stefano  6   7 , Christoph P Beier  8 , Raoul Sutter  9   10 , Leena Kämppi  11 , Daniel Strbian  11 , Erik Taubøll  12 , Felix Rosenow  5 , Raimund Helbok  13 , Stephan Rüegg  11 , Maxwell Damian  14 , Eugen Trinka  2   3   15   16 , Nicolas Gaspard  17   18
Affiliations
Multicenter Study

Sustained effort network for treatment of status epilepticus/European academy of neurology registry on adult refractory status epilepticus (SENSE-II/AROUSE)

Charlotte Damien et al. BMC Neurol. .

Abstract

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.

Keywords: Anti-seizure medication; Continuous intravenous anesthetic Drugs; EEG; Outcome; Refractoriness; Status Epilepticus.

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Conflict of interest statement

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 Kämppi 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 Rüegg 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, Böhringer 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), Österreichische 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 Médicale and INNOVIRIS; honoraria from MedLink Neurology.

Other authors declare that they have no competing interest.

References

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