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

Status Epilepticus Clinical Trial

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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Status Epilepticus

• NCT number: NCT05839418
• Study type: Observational [Patient Registry]
• Source: Erasme University Hospital
• Contact: Nicolas Gaspard, MD, PhD
• Phone: 00325553429
• Email: Nicolas.Gaspard@erasme.ulb.ac.be
• Status: Recruiting
• Start date: March 1, 2023
• Completion date: December 31, 2028