SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.
SENSE-II/AROUSE is a prospective, multicenter, non-randomized, observational registry study of consecutive cases of SE. We aimed to include university hospitals as well as non-university hospitals to enhance generalizability of the findings. Currently, 13 high-volume medical centers in Belgium, Austria, Germany, United Kingdom, Switzerland, No common management protocol will be imposed on the participating centers. However, most institutions have established a local protocol that is closely related to the most recent guidelines for the management of SE published by the American Epilepsy Society (AES) in 2016. We will exclude patients with anoxic status epilepticus after cardiac arrest and patients younger than 18 years. Clinical and EEG Data will be collected prospectively from the admission of the patient to the discharge. Data collection will be performed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Erasme Hospital in Brussels, Belgium. To reach sufficient statistical power for multivariate analysis, a cohort size of 3000 patients is targeted. The main objective of the study is to document patient characteristics, treatment modalities, EEG features and outcome of adults treated for SE and identify predictors of outcome. The data collected in this study could also identify gaps and opportunities for the management of this medical emergency. Lacking adequate prospective controlled trials, this will help both decision-making in clinical practice and designing future clinical trials. Moreover, EEG data will help for a better electroencephalographic definition of SE, possible SE, and some boundary conditions, such as ictal-interictal continuum.
Study Type
OBSERVATIONAL
Enrollment
3,000
Kepler University Linz
Linz, Austria
NOT_YET_RECRUITINGChristian Doppler Klinik of Paracelsus Medical University
Salzburg, Austria
NOT_YET_RECRUITINGModified Rankin Scale
Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
Time frame: On the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Refractoriness
Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.
Time frame: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Modified Rankin Scale
Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
Time frame: At 30 days after the date of inclusion or SE onset (if still hospitalized)
Modified Rankin Scale
Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
Time frame: At 3 months after the date of discharge from hospital
Super-refractoriness
Super-refractory status epilepticus is defined as Status Epilepticus persisting or recurring after 24 hours or more of treatment with continuous intravenous anesthetic drugs or when therapy is tapered after 24 hours of use.
Time frame: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
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HUB Erasme
Brussels, Belgium
Odense University Hospital & Svenborg Hospital
Odense, Denmark
RECRUITINGHelsinki University Central Hospital
Helsinki, Finland
NOT_YET_RECRUITINGGoethe-Universität Frankfurt am Main
Frankfurt, Germany
NOT_YET_RECRUITINGEpilepsy Center Münster-Osnabrück, Klinikum Osnabrück
Osnabrück, Germany
NOT_YET_RECRUITINGOslo University Hospital
Oslo, Norway
NOT_YET_RECRUITINGUniversity Hospital Basel
Basel, Switzerland
NOT_YET_RECRUITINGUniversity Hospital of Geneva
Geneva, Switzerland
NOT_YET_RECRUITING...and 1 more locations