Posterior Reversible Encephalopathy Syndrome 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
- 300
- 试验地点
- 1
- 主要终点
- Favorable outcome
研究概览
简要总结
Posterior Reversible Encephalopathy Syndrome prospective (PRES) registry. Data collection using a standardized form : demographic data and data related to the PRES, including circumstances of onset, dates and times of onset and of symptoms control, on-scene clinical findings, clinical and radiological features of PRES, pre-hospital and hospital care providers, timing of antiepileptic, antihypertensive drugs and supportive treatments, results of etiological investigations, cause of PRES, type and dosage of antiepileptic and antihypertensive drugs. Dates and times of EEG monitoring, EEG results, radiological and biological investigations. 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
- •age >= 18 years
- •Posterior Reversible Encephalopathy Syndrome defined as:
- •combination of consciousness impairment, seizure activity, headaches, visual abnormalities, nausea/vomiting, and focal neurological signs AND
- •cerebral imaging abnormalities involving the white matter (brain CT scan hypodensities AND/OR Brain MRI hypoT1, hyper T2 FLAIR)
- •intensive care unit admission
排除标准
- •normal cerebral imaging
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 during a structured 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
- Functional impairment(3-months and 1-year, 5-years, 10-years)
- Recurrent PRES(3-months and 1-year, 5-years, 10-years)
- Favorable outcome(3-months and 5-years, 10-years)
- Low or moderate disability(3-months and 1-year, 5-years, 10-years)
- Mortality rate(ICU, hospital discharge, 3-months and 1-year, 5-years, 10-years)