Risk Factors in Sudden Unexpected Death in Epilepsy of the Adults and Children: A Matched Case-control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Risk factors for SUDEP
研究概览
简要总结
Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.
This epidemiological study is based on the RSME. The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.
详细描述
Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.
A French national network on epilepsy related death (Reseau Sentinelle Mortalité Epilepsie, RSME) will be initially established in 2010 by the French League Against Epilepsy (LFCE) under the leadership of bereaved families and supported by the French Foundation for Epilepsy Research (FFRE). This epidemiological study is based on the RSME.
The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.
The study design is an epidemiological case-control study. The cases are SUDEP identified in the RSME and French centres of Epileptology.
Epilepsy-related deaths are reported by physicians but also by bereaved families. An interview with a psychologist will be proposed at this moment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Cases : Any patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years who died as a result of confirmed or probable SUDEP or NEAR SUDEP during the study period.
- •Controls : Patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years and matched by: age, epileptic syndrom and level of seizure controls
排除标准
- •For cases and controls :patient not living in France, refusal of participation
结局指标
主要结局
Risk factors for SUDEP
时间窗: 1 day
* Lifestyle (night-time supervision ...), habits (alcohol consumption ...) * Personal cardiac history (arrhythmias, ECG abnormalities ...), respiratory, sleep apnoea, muscular or neurological disorders, mental retardation, associated psychiatric disorders... * Antiepileptic drugs
次要结局
- Familial Risk factors for SUDEP(1 day)
- Needs and expectations of bereaved families on epilepsy related death information(1 day)