Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

Status Epilepticus Clinical Trial

— SENSEII/AROUSE  

Official title:

Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05839418
• Other study ID #: P2020/483/B4062020000170
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2023
• Source: Erasme University Hospital
• Contact: Nicolas Gaspard, MD, PhD
• Phone: 00325553429
• Email: Nicolas.Gaspard[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Status Epilepticus

Locations

Country	Name	City	State
Austria	Kepler University Linz	Linz
Austria	Christian Doppler Klinik of Paracelsus Medical University	Salzburg
Belgium	HUB Erasme	Brussel
Denmark	Odense University Hospital & Svenborg Hospital	Odense
Finland	Helsinki University Central Hospital	Helsinki
Germany	Goethe-Universität Frankfurt am Main	Frankfurt
Germany	Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück	Osnabrück
Norway	Oslo University Hospital	Oslo
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital of Geneva	Geneva
United Kingdom	Birmingham University Hospitals NHS Trust	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  Germany,  Norway,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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)
Secondary	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 3 months after the date of discharge from hospital
Secondary	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