Manipulation of Arterial Pressure Early in Non Thrombolysed Acute Ischemic Stroke: Effects on Death and Neurological Disability
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Ranking score and mortality
研究概览
简要总结
This is a controlled clinical trial among non thrombolysed acute ischemic stroke patients to determine the effects of three levels of arterial pressure on death and neurological disability. After the admission in the vascular unit of the Emergency Department the patients are randomized to maintain during the first 24h the Systolic Arterial Pressure in tree levels of pressure: 140 to 160 mmHg; 161 to 180 mmHg and 181 to 200 mmHg. The end point of the study is the Modified Rankin score and mortality in three month after the discharge.
详细描述
To maintain the tree levels of systolic arterial pressure during de first 24h we will use one of the two strategies:1) infusion of 500 to 1000ml of saline solution and/or norepinephrine solution to increase de systolic pressure or 2) infusion of esmolol or nitroprussiate solution to decrease de pressure. Every patient will have a transcranial doppler study in the first 24h to measure the mean velocity of cerebral arteries.
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
- 是
入选标准
- •Patients 18 years or older, with the first Acute Ischemic Stroke within the first 6 hours of the symptoms and not candidate to thrombolysis
- •We will also include patients with previous Ischemic Stroke with Ranking score 0 or 1
排除标准
- •Improuvment of the symptoms rapidly (in the first 15 min after admission)
- •Seizures not related do the acute ischemic stroke
- •Previous ischemic stroke in the last 6 weeks and with Ranking score > 1
- •Haemorrhagic stroke
- •Anticoagulation
- •Hypoglycemia
- •Acute heart failure
研究组 & 干预措施
1, 140 to 160 mmHg
Esmolol, NPS or NOR
干预措施: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR) (Drug)
1, 140 to 160 mmHg
Esmolol, NPS or NOR
干预措施: Esmolol, NPS or NOR (Drug)
1, 140 to 160 mmHg
Esmolol, NPS or NOR
干预措施: manipulation of SAP (Drug)
2, 161 to 180 mmHg
Esmolol, NPS or NOR
干预措施: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR) (Drug)
2, 161 to 180 mmHg
Esmolol, NPS or NOR
干预措施: Esmolol, NPS or NOR (Drug)
2, 161 to 180 mmHg
Esmolol, NPS or NOR
干预措施: manipulation of SAP (Drug)
3, 181 to 200 mmHg
Esmolol, NPS or NOR
干预措施: Esmolol, Sodium Nitroprussiate (NPS) or Norepinephrine (NOR) (Drug)
3, 181 to 200 mmHg
Esmolol, NPS or NOR
干预措施: Esmolol, NPS or NOR (Drug)
3, 181 to 200 mmHg
Esmolol, NPS or NOR
干预措施: manipulation of SAP (Drug)
结局指标
主要结局
Ranking score and mortality
时间窗: Three month
次要结局
未报告次要终点