buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest (RESTORE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post-cardiac arrest refractory status epilepticus control
研究概览
简要总结
RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.
详细描述
Rationale: Seizures emerge as a complication of hypoxic-ischemic brain injury in near a third of patients successfully resuscitated from cardiac arrest. Seizures post-cardiac arrest can be refractory to treatment with anti-seizure medications and anesthetics may be used for refractory status epilepticus control. Anesthetic treatment guided by continuous EEG can target burst suppression or seizure suppression, however it is not known which strategy is superior for achieving PCARSE control.
Objective: determine the safety and feasibility of post-cardiac arrest refractory status epilepticus (PCARSE) treatment using EEG goals for intravenous anesthetic titration (burst suppression vs. seizure suppression).
Clinical Trial Phase: II
Study Design: prospective, randomized, open-label, blinded end-point, concurrently-controlled, parallel arms design clinical trial.
Study Period: two years
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years old
- •Non-traumatic, out-of-hospital cardiac arrest
- •Comatose on admission - defined as not following commands
- •Return of spontaneous circulation (ROSC) within less than 45 minutes
- •Admission to the intensive care unit
- •Diagnosis of post-cardiac arrest refractory status epilepticus confirmed with continuous
- •EEG monitoring within 7 days from ROSC
排除标准
- •Acute cerebral hemorrhage or infarction
研究组 & 干预措施
Burst Suppression EEG Target
Anesthetic will be titrated to achieve burst suppression on continuous EEG (50-99% attenuation/suppression) for 24 hours.
干预措施: Burst Suppression EEG Target Intravenous Anesthesia (Drug)
Seizure Suppression EEG Target
Anesthetic will be titrated to achieve seizure suppression on continuous EEG for 24 hours.
干预措施: Seizure Suppression EEG Target Intravenous Anesthesia (Drug)
结局指标
主要结局
Post-cardiac arrest refractory status epilepticus control
时间窗: 48 hours
Continuous EEG will be monitored to determine time to PCARSE recurrence during the anesthetic maintenance and anesthetic weaning phase (combined)
次要结局
- Neurological Function at Discharge (CPC: Cerebral Performance Category)(30 days)
- Seizure recurrence incidence and duration (burden)(24-48 hours)
- PCARSE Treatment Intensity(24-48 hours)
- Neurological Function at Discharge (mRS: modified Ranking Scale)(30 days)
- Neurological Function 90 days (CPC: Cerebral Performance Category)(90 days)
- Neurological Function 90 days (mRS: modified Ranking Scale)(90 days)
- Neurological Function 180 days (mRS: modified Ranking Scale)(180 days)
- Neurological Function180 days (mRS: modified Ranking Scale)(180 days)