Clinical trial NCT05839418: Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
Official title: Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Status Epilepticus
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of and above 18 years admitted for Status Epilepticus management or who develop Status Epilepticus during their hospital stay

Brief summary: 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.

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

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: On the date of discharge from hospital or date of death from any cause, assessed up to 24 months
measure: Refractoriness
timeFrame: 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 outcomes:
measure: Modified Rankin Scale
timeFrame: At 30 days after the date of inclusion or SE onset (if still hospitalized)
measure: Modified Rankin Scale
timeFrame: At 3 months after the date of discharge from hospital
measure: Super-refractoriness
timeFrame: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler University Linz
city: Salzburg
country: Austria
facility: Christian Doppler Klinik of Paracelsus Medical University
city: Brussel
country: Belgium
facility: HUB Erasme
city: Odense
country: Denmark
facility: Odense University Hospital & Svenborg Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Frankfurt
country: Germany
facility: Goethe-Universität Frankfurt am Main
city: Osnabrück
country: Germany
facility: Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
city: Birmingham
country: United Kingdom
facility: Birmingham University Hospitals NHS Trust
Study officials:
affiliation: Erasme UH
name: Nicolas Gaspard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: