Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Safety outcome: Side effect
研究概览
简要总结
Lacunar infarction is an ischemic stroke occurred by small perforating artery occlusion . Twenty percent of ischemic stroke is lacunar infarction.
However, outcome of lacunar infarction is excellent, about 20-40% patients are suffered neurological worsening.
Progressive lacunar infarction is associated poor functional outcome and neurological deficit.
Currently, no treatment for progressive lacunar infarction is recommended on the guideline.
Several small study reported that phenylephrine and magnesium may be helpful for progressive lacunar infarction.
Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia.
CO2 dilate cerebral arteriole and concentration of CO2 is correlated with cerebral blood flow.
Lacunar infarction is small and perfused with marginal flow by neighboring perforating arteriole.
Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressive lacunar infarction.
Induced hypertension is alternative treatment of progressive lacunar infarction. Increasing blood pressure also induce cerebral blood flow.
Phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart.
Several studies reported that the effectiveness of phenylephrine on progressing stroke.
Therefore, this study will compare the effectiveness of carbogen versus phenylephrine in lacunar infarction patients who suffered neurological worsening.
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)
盲法说明
Three months after discharge, the independence assessment will be performed by the researcher who don't know the patients group.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 years
- •Anterior circulation progressive lacunar infarction.
- •Neurological worsening either 1 point in NIHSS score or MRC grade
排除标准
- •Cortical infarction
- •Posterior circulation lacunar infarction
- •Relevant artery stenosis more than 50% or occlusion
- •Moyamoya disease
- •Difficulty in inhalation of Carbogen (panic, severe anxiety disorder)
- •Drug allergy for phenylephrine
- •Persistent bradycardia (pulse rate < 50 /min)
- •History of hemorrhagic stroke
- •Pre-stroke mRS ≥2
研究组 & 干预措施
Phenylephrine group
干预措施: phenylephrine (Drug)
Carbogen group
干预措施: carbogen (Drug)
结局指标
主要结局
Safety outcome: Side effect
时间窗: within 7 days
Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
Safety outcome: discontinuing patients
时间窗: within 7 days
Number of discontinuing patients due to side effects
percent improvement of NIHSS score in each group
时间窗: 48 hours
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
difference of NIHSS score in each group
时间窗: 48 hours
baseline NIHSS score-post-treatment NIHSS score
percent improvement of MRC score in each group
时间窗: within 48 hours
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
difference of MRC score in each group
时间窗: within 48 hours
baseline MRC score-post-treatment MRC score
次要结局
- Comparison between groups by percent improvement of NIHSS score(48 hours)
- Comparison between groups by difference of NIHSS score(48 hours)
- Comparison between groups by percent improvement in MRC score(within 48 hours)
- Comparison between groups by difference of MRC score(within 48 hours)
- Functional independence(upon discharge, 3 months after onset)