Assessment of Seizure Prophylaxis Protocols Using Intravenous Levetiracetam in a Neuroscience Intensive Care Unit
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Seizure Incidence
研究概览
简要总结
To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and sub-clinical seizure activity.
详细描述
To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prophylaxis in the Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the current standard of care anticonvulsant(phenytoin) and will be at least as effective as phenytoin in preventing clinical and sub-clinical seizure activity.
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
- Single (Outcomes Assessor)
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
- •Subjects with traumatic brain injury
- •Glasgow Coma Score (GCS) score 3-8(inclusive),or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
- •Hemodynamically stable with a systolic BP >90 mm Hg
- •At least one reactive pupil
- •A negative pregnancy test in females
- •Age at least 18 years
- •Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR
- •Subjects with subarachnoid hemorrhage (SAH)
- •SAH documented by CT scan
- •Hunt-Hess grade 3-5, inclusive
- •Hemodynamically stable with a systolic BP> 90 mm Hg
- •At least one reactive pupil
- •A negative pregnancy test in females
- •Age of at least 18 years
- •Signed informed consent and HIPAA authorization for research form
- •Exclusion Criteria for enrollment
- •No venous access
- •Spinal cord injury
- •History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
- •Hemodynamically unstable
- •Suspected anoxic events
- •Other peripheral trauma likely to result in liver failure
- •Positive pregnancy test in females
- •Age less than 18 years of age
- •Known hypersensitivity to any anticonvulsant
- •An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.
- •Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).
- •Inability to obtain signed informed consent or HIPAA authorization for research.
排除标准
- 未提供
研究组 & 干预措施
Levetiracetam
Group 1 - The levetiracetam (Keppra®) group will receive a loading dose of 20 mg/kg IV over 15 minutes (rounded to the nearest 250mg) up to a maximum of 2000 mg, then started on maintenance dose (1000 mg, IV BID)as prophylaxis for 7 days.
干预措施: Levetiracetam (Drug)
Phenytoin
Group 2-The phenytoin group will receive a loading dose of 20 mg/kg IV to a maximum of 2000mg, then started on maintenance dose at 5 mg/kg/day (rounded to nearest 100mg dose, IV, divided into three doses a day) as prophylaxis for 7 days. Phenytoin levels are to be checked daily and dose adjusted as needed to maintain therapeutic levels of 10-20 µg/dL.
干预措施: Phenytoin (Drug)
结局指标
主要结局
Seizure Incidence
时间窗: Duration of study, up to 6 months after the injury
This was the number of patients in each group who demonstrated seizure activity during the course of the study
次要结局
- Extended Glasgow Outcome Score(at discharge; 3 and 6 months following injury)
- Disability Rating Scale (DRS)(Discharge; 3 and 6 months following injury)
- Incidence of Adverse Events(discharge; 3 and 6 months following injury)
研究者
Lori Shutter
Director, Neurocritical Care Fellowship Program
University of Pittsburgh