Making SENSE - Sustained Effort Network for treatment of Status Epilepticus as a multicenter prospective registry

Abstract

BackgroundEvidence regarding the different treatment options of status epilepticus (SE) in adults is scarce. Large randomized trials cover only one treatment at early stage and suggest the superiority of benzodiazepines over placebo, of intravenous lorazepam over intravenous diazepam or over intravenous phenytoin alone, and of intramuscular midazolam over intravenous lorazepam. However, many patients will not be treated successfully with the first treatment step. A large randomized trial covering the treatment of established status (ESETT) has just been funded recently by the NIH and will not start before 2015, with expected results in 2018; a trial on the treatment of refractory status with general anesthetics was terminated early due to insufficient recruitment. Therefore, a prospective multicenter observational registry was set up; this may help in clinical decision-making until results from randomized trials are available.Methods/DesignSENSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patient characteristics, treatment modalities and in-house outcome of consecutive adults admitted for SE treatment in each of the participating centres and to identify predictors of outcome. Pre-treatment, treatment-related and outcome variables are documented systematically. To allow for meaningful multivariate analysis in the patient subgroups with refractory SE, a cohort size of 1000 patients is targeted.DiscussionThe results of the study will provide information about risks and benefits of specific treatment steps in different patient groups with SE at different points of time. Thus, it will support clinical decision-making and, furthermore, it will be helpful in the planning of treatment trials.Trial registrationDRKS00000725

Factors predicting cessation of status epilepticus in clinical practice: Data from a prospective observational registry (SENSE)

“…On the other hand, our database documents “real‐life” treatment in clinical practice, in centers with special interest in SE treatment, and the previously published, standardized ascertainment protocol should limit marked internal bias . The number of patients included was clearly higher than in comparable registries or trials.…”

“…The methods and design of the SENSE registry have been published elsewhere . In brief, eight centers with special expertise in SE treatment in German‐speaking countries participated and recruited patients: Germany: Epilepsy Centre University Marburg, University Hospital Schleswig‐Holstein Campus Kiel, Klinikum Osnabrück, Krankenhaus Barmherzige Brüder Regensburg; Austria: Christian‐Doppler‐Klinik, Universitätsklinikum der Paracelsus Medizinischen Universität Salzburg, Department of Neurology, Innsbruck Medical University; Switzerland: University Hospital Basel, University Hospital Lausanne (the only French‐speaking site).…”

“…Therefore, a working group of centers from German‐speaking countries established a prospective registry for patients treated for SE, with the acronym SENSE (Sustained Effort Network for treatment of Status Epilepticus) . It includes data on all treatment stages reflecting clinical practice, which were evaluated to determine predictors of cessation of SE within the first hour (for generalized convulsive SE [GCSE]) and initial 12 hours (for non‐GCSE) of treatment.…”

Etiologies and characteristics of refractory status epilepticus cases in different areas of the world: Results from a global audit

“…At this stage, most protocols suggest treatment with continuous intravenous anesthetic drugs to promptly stop seizure activity and prevent long-term neuronal damage, further refractoriness, 4,5 and severe acute systemic consequences, especially in convulsive status epilepticus (SE). 7,8 The underlying etiology of SE is considered the most important prognostic factor determining outcome. 6 For these reasons, there has been an increasing interest in multinational registries.…”

“…6 For these reasons, there has been an increasing interest in multinational registries. 7,8 The underlying etiology of SE is considered the most important prognostic factor determining outcome. 9 Apart from the treatment, etiology itself significantly differs in developing countries as compared to the Western world, with acute symptomatic etiologies being more frequent in developing countries.…”