Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Intracranial pressure control
研究概览
简要总结
Objective: to assess the effectiveness of pentobarbital and thiopental to control raised intracranial pressure (ICP), refractory to first level measures, in patients with severe traumatic brain injury.
Material and methods: prospective, randomized open study to compare the effectiveness between two treatments: pentobarbital and thiopental. The patients will be selected from those admitted to the Intensive Care Unit with a severe traumatic brain injury (postresuscitation Glasgow Coma Scale equal or less than 8 points) and raised ICP (ICP>20 mmHg) refractory to first level measures according to the Brain Trauma Foundation guidelines. The adverse effects of both treatments were also collected.
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 (Participant)
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a severe closed head injury and a post-resuscitation Glasgow Coma Scale (GCS) score below or equal to 8
- •Age between 15 and 76 years (inclusive)
- •High ICP (> 20 mm Hg) refractory to first-tier therapeutic measures according to BTF guidelines (1)
- •Hemodynamic stability defined as a systolic blood pressure of at least 100 mm Hg or above at the moment of entering the trial
- •Written informed consent obtained from next-of-kin or the patient's legally authorized representative
排除标准
- •Previously known ischemic heart failure (Ejection fraction < 35%)
- •Pregnancy
- •bilateral dilated and unreactive pupils and a GCS of 3
- •Intolerance to barbiturates
研究组 & 干预措施
1
Pentobarbital
干预措施: Pentobarbital (Drug)
2
thiopental
干预措施: thiopental (Drug)
结局指标
主要结局
Intracranial pressure control
时间窗: along intensive care unit stay
次要结局
- Hypotension (Mean arterial blood pressure<80 mmHg)(during barbiturate treatment)
- Infection(during barbiturate treatment)