Observational Study on Dynamic Changes of Blood Pressure During Post-epileptic Seizure Stage: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Comparison of baseline blood pressure versus post-epileptic seizure blood pressure (systolic and diastolic)
研究概览
简要总结
This article details a multicenter study on changes of blood pressure and heart rate during post-epileptic seizure stage.
详细描述
In contrast to the well-documented changes in heart rate and respiration, post-seizure changes in blood pressure have received insufficient attention. Fluctuations in blood pressure may worsen brain injury and elevate the risk of Sudden Unexpected Death in Epilepsy (SUDEP), yet evidence regarding postictal blood pressure changes remains limited.
This multicenter study aims to investigate the changes of blood pressure and heart rate during post-epileptic seizure stage in epilepsy patients, providing high-quality evidence on postictal hemodynamic changes and laying the foundation for future interventions. The study will enroll 1100 seizure events from hospitalized epilepsy patients aged 14-80 years between October 2024 and March 2026. Data on blood pressure, heart rate and blood oxygen will be collected during multiple time intervals post-seizure, alongside clinical information such as seizure type, duration, and medication use.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14-80 years old, male and female;
- •Meet the diagnostic criteria for epilepsy, including focal epilepsy and generalized epilepsy.
- •Patients diagnosed with epilepsy, with at least one seizure during the hospitalization.
- •Seizures lasting longer than 30 seconds (including convulsive and non-convulsive status epilepticus, if seizure cessation can be determined and medications were recorded, they can be included).
- •Hypertensive patients who are on antihypertensive medication and have well-controlled blood pressure are eligible.
- •Patients who agree to participate in the study.
排除标准
- •Patients with structural heart disease, coronary artery disease (CAD), cardiomyopathy
- •Patients with severe systemic diseases
- •Preictal seizures or myoclonic seizures.
结局指标
主要结局
Comparison of baseline blood pressure versus post-epileptic seizure blood pressure (systolic and diastolic)
时间窗: within 1 hour
Baseline blood pressure and blood pressure measurements (systolic and diastolic) immediately after seizure (0-1 minute), at 3 minutes (2-4 minutes), 5 minutes (4-6 minutes), 10 minutes (9-11 minutes), 20 minutes (19-21 minutes), 30 minutes (29-31 minutes), and 60 minutes (59-61 minutes) post-seizure.
次要结局
- Comparison of baseline blood-oxygen versus post-epileptic seizure blood-oxygen(within 1 hour)
- Comparison of baseline heart rate versus post-epileptic seizure heart rate(within 1 hour)
研究者
Liankun_Ren
Professor
Xuanwu Hospital, Beijing