CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN(CARBOGEN Trial)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- percent improvement of NIHSS score in each group
研究概览
简要总结
Progressing stroke is associated poor functional outcome and neurological deficit.
Currently, no treatment for progressing stroke is recommended on the guideline.
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.
Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressing stroke.
Induced hypertension is alternative treatment of progressing stroke. 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 + phenyleprhine versus phenlyephrine in progressing stroke patients.
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 perfomred by the researcher who don't know the patietns 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 progressing stroke
- •Neurological worsening either 1 point in NIHSS score or MRC grade
排除标准
- •Age under 20 years.
- •Patients with cerebral infarction who are at risk of cerebral edema as determined by the investigator.
- •Patients with Moyamoya disease.
- •Patients with severe cerebrovascular reactivity (CVR) impairment due to cerebral vascular stenosis, making study participation challenging as determined by the investigator.
- •Patients unable to undergo CO2 treatment (e.g., panic disorder, anxiety disorders, or other psychiatric conditions).
- •Patients with hypersensitivity to phenylephrine.
- •Patients with persistent bradycardia (heart rate < 50 bpm).
- •Patients with a history of hemorrhagic stroke or at risk of cerebral hemorrhage.
- •Patients with a pre-stroke modified Rankin Scale (mRS) score ≥ 2, indicating impaired functional independence.
- •Patients ineligible for phenylephrine treatment due to any of the following:
- •Myocardial infarction or unstable angina within the past 3 months. Cardiac ejection fraction < 25%. Ventricular arrhythmia. Systolic blood pressure > 200 mmHg. Serum creatinine > 2 mg/dL. Pregnancy.
- •Use of monoamine oxidase (MAO) inhibitors.
- •Patients who do not consent to participate in the study.
研究组 & 干预措施
Carbogen + phenylephrine group
干预措施: carbogen with or without phenyleprhine (Drug)
Phenylephrine group
干预措施: phenylephrine (Drug)
结局指标
主要结局
percent improvement of NIHSS score in each group
时间窗: 24 hours
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
difference of NIHSS score in each group
时间窗: 24 hours
baseline NIHSS score-post-treatment NIHSS score
difference of MRC score in each group
时间窗: difference of MRC score in each group
baseline MRC score-post-treatment MRC score
Saftety outcome: discontinuing patients
时间窗: within 7 days
Number of discontinuing patients due to side effects
percent improvement of MRC score in each group
时间窗: within 24 hours
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
Saftety outcome: Side effect
时间窗: within 7 days
Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
次要结局
- Comparision between groups by percent improvement of NIHSS score(24 hours)
- Comparision between groups by difference of MRC score(within 24 hours)
- Functional independencec(3 months after onset)
- Comparision between groups by differnece of NIHSS score(24 hours)
- Comparision between groups by percent improvement in MRC score(within 24 hours)