SENSEII/AROUSE: Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
Study Details
Study Description
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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Modified Rankin Scale [On the date of discharge from hospital or date of death from any cause, assessed up to 24 months]
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).
- Refractoriness [From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months]
Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.
Secondary Outcome Measures
- Modified Rankin Scale [At 30 days after the date of inclusion or SE onset (if still hospitalized)]
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).
- Modified Rankin Scale [At 3 months after the date of discharge from hospital]
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).
- Super-refractoriness [From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 18 years or above
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Patients admitted for management of Status Epilepticus as their primary diagnosis
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Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay
Exclusion Criteria:
- Patients with post-cardiac arrest SE
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kepler University Linz | Linz | Austria | ||
| 2 | Christian Doppler Klinik of Paracelsus Medical University | Salzburg | Austria | ||
| 3 | HUB Erasme | Brussel | Belgium | 1070 | |
| 4 | Odense University Hospital & Svenborg Hospital | Odense | Denmark | ||
| 5 | Helsinki University Central Hospital | Helsinki | Finland | ||
| 6 | Goethe-Universität Frankfurt am Main | Frankfurt | Germany | ||
| 7 | Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück | Osnabrück | Germany | D-49078 | |
| 8 | Oslo University Hospital | Oslo | Norway | ||
| 9 | University Hospital Basel | Basel | Switzerland | ||
| 10 | University Hospital of Geneva | Geneva | Switzerland | ||
| 11 | Birmingham University Hospitals NHS Trust | Birmingham | United Kingdom |
Sponsors and Collaborators
- Erasme University Hospital
Investigators
- Principal Investigator: Nicolas Gaspard, MD, PhD, Erasme UH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P2020/483/B4062020000170