Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Status Epilepticus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Belgium, Denmark, Finland, Germany +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Modified Rankin Scale [Time frame: On the date of discharge from hospital or date of death from any cause, assessed up to 24 months]
- Refractoriness [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]
Secondary outcome measures (3)
- Modified Rankin Scale [Time frame: At 30 days after the date of inclusion or SE onset (if still hospitalized)]
- Modified Rankin Scale [Time frame: At 3 months after the date of discharge from hospital]
- Super-refractoriness [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]
Eligibility criteria
Inclusion criteria
- Patients aged 18 years or above
- Patients admitted for management of Status Epilepticus as their primary diagnosis
- Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay
Exclusion criteria
\- Patients with post-cardiac arrest SE
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 2 centers
- Kepler University Linz — Linz
- Christian Doppler Klinik of Paracelsus Medical University — Salzburg
Germany · 2 centers
- Goethe-Universität Frankfurt am Main — Frankfurt
- Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück — Osnabrück
Switzerland · 2 centers
- University Hospital Basel — Basel
- University Hospital of Geneva — Geneva
Belgium · 1 center
- HUB Erasme — Brussels
Denmark · 1 center
- Odense University Hospital & Svenborg Hospital — Odense
Finland · 1 center
- Helsinki University Central Hospital — Helsinki
Norway · 1 center
- Oslo University Hospital — Oslo
United Kingdom · 1 center
- Birmingham University Hospitals NHS Trust — Birmingham
Publications
- Damien C, Leitinger M, Kellinghaus C, Strzelczyk A, De Stefano P, Beier CP, Sutter R, Kamppi L, Strbian D, Tauboll E, Rosenow F, Helbok R, Ruegg S, Damian M, Trinka E, Gaspard N. Sustained effort network for treatment of status epilepticus/European academy of neurology registry on adult refractory status epilepticus (SENSE-II/AROUSE). BMC Neurol. 2024 Jan 4;24(1):19. doi: 10.1186/s12883-023-03505- PMID 38178048
Identifiers
NCT: NCT05839418 · P2020/483/B4062020000170