Status Epilepticus in the Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ictal Group
- 入组人数
- 1,000
- 试验地点
- 20
- 主要终点
- Favorable outcome
研究概览
简要总结
Convulsive and Non Convulsive Status Epilepticus (SE) and Pseudo Status Epilepticus prospective registry.
Data collection using a standardized form : demographic data and data related to the SE, including circumstances of onset, dates and times of onset and of seizure control, on-scene clinical findings, clinical features of the seizures, pre-hospital and hospital care providers, timing of antiepileptic and supportive treatments, results of etiological investigations, cause of SE, type and dosage of antiepileptic drugs. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview.
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
- 是
入选标准
- •SE defined as 5 min or more of (i) continuous clinical and/or electrographic seizure activity or (ii) recurrent seizure activity without recovery (returning to baseline) between seizures.
- •age >= 18 years
排除标准
- •age < 18 years
- •postanoxic status epilepticus
结局指标
主要结局
Favorable outcome
时间窗: 1 year
A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined according to patients charts review and/or general practitioner interview conducted by an independent assessor. The GOS score : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]
次要结局
- refractory status epilepticus(24 hours)
- super refractory status epilepticus(72 hours)
- total ICU and in-hospital length of stay(90 days)
- mortality rate(ICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years)
- Favorable outcome(3 months, 5-years and 10 years)
- Functional impairment(3 months, and 1-year, 5-years and 10-years)
- total seizure duration(72 hours)
- percentages of the patients that experience recurrent convulsive and/or non-convulsive seizures within 12 hours after ICU admission(12 hours)