Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 11
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with post-cardiac arrest SE
结局指标
主要结局
Modified Rankin Scale
时间窗: 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
时间窗: 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.
次要结局
- Modified Rankin Scale(At 3 months after the date of discharge from hospital)
- 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)