Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 30 days after the date of inclusion or SE onset (if still hospitalized) |
| Modified Rankin Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Patients with post-cardiac arrest SE
Not provided
Not provided
Not provided
All patients of and above 18 years admitted for Status Epilepticus management or who develop Status Epilepticus during their hospital stay
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Gaspard, MD, PhD | Contact | 00325553429 | Nicolas.Gaspard@erasme.ulb.ac.be | |
| Charlotte Damien, MD | Contact | 00325553429 | Charlotte.Damien@erasme.ulb.ac.be |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Gaspard, MD, PhD | Erasme UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler University Linz | Not yet recruiting | Linz | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38178048 | Derived | 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-y. |
Not provided
Not provided
All collected IPD will be shared with other researchers. not public upon reasonable request
Data will be deidentified and collected through RedCap by each local investigator.
IPD will be accessible and shared only with the researchers involved in this registry.
These de-identified data will be available for the duration of the registry and on reasonable request to Nicolas Gaspard after publication of the results.
IPD will be accessible only by the researchers involved in the building of this registry.
Not provided
Not provided
Not provided
Not provided
Not provided
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). |
| 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. | From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months |
| Christian Doppler Klinik of Paracelsus Medical University | Not yet recruiting | Salzburg | Austria |
|
| HUB Erasme | Recruiting | Brussels | 1070 | Belgium |
|
| Odense University Hospital & Svenborg Hospital | Recruiting | Odense | Denmark |
|
| Helsinki University Central Hospital | Not yet recruiting | Helsinki | Finland |
|
| Goethe-Universität Frankfurt am Main | Not yet recruiting | Frankfurt | Germany |
|
| Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück | Not yet recruiting | Osnabrück | D-49078 | Germany |
|
| Oslo University Hospital | Not yet recruiting | Oslo | Norway |
|
| University Hospital Basel | Not yet recruiting | Basel | Switzerland |
|
| University Hospital of Geneva | Not yet recruiting | Geneva | Switzerland |
|
| Birmingham University Hospitals NHS Trust | Not yet recruiting | Birmingham | United Kingdom |
|
| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided