An Open-Label Prospective Study to Evaluate the Safety and Efficacy of Double or Triple Concentrated Intravenous Nicardipine for Treatment of Hypertension in Patients With Ischemic Stroke, Intracerebral Hemorrhage or Subarachnoid Hemorrhage
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- • Demonstrate the feasibility and safety of double and triple concentrated peripheral intravenous Nicardipine for patients in the Neuroscience Critical Care Unit.
研究概览
简要总结
Hypertension (high blood pressure) can often cause neurological worsening in patients with stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The purpose of this study is to evaluate safety and efficacy of double or triple concentrated peripheral intravenous (IV) Nicardipine.
详细描述
Hypertension can often cause neurological worsening in patients with either ICH or SAH. Hypertension has been related to increased incidence of intracranial hemorrhage in patients who are treated with thrombolytics or on anticoagulation. Timely control of hypertension is directly related to the outcome of these patients. Furthermore, unlike in the conditions of hypertensive emergency or urgency, gentle titration to control the blood pressure is recommended in patients with either ischemic cerebral infarction or hemorrhage. Therefore the ideal agent to control hypertension in these patients would have these characteristics:
- Rapid onset of action
- Predictable dose response
- Titratable to desired BP
- Minimal dosage adjustments
- Minimal adverse effects
- No increase in INTRACRANIAL PRESSURE (ICP)
- Easy transition to oral formulation for long-term maintenance
Currently, only IV sodium nitroprusside, nitroglycerine, enalapril and esmolol are used for controlling blood pressure in patients with IS, ICH and SAH. These agents are difficult to titrate and may potentially be harmful to brain cells.
Nicardipine offers several advantages in blood pressure control. It may cause dilatation of the coronary vessels while has no effect on cardiac conduction. It is not associated with coronary steal. As the only IV calcium channel blocker approved for the treatment of hypertension, nicardipine is vasoselective, and has a rapid onset and precisely controllable in a variety of patient types. It is as effective as sodium nitroprusside with fewer dose adjustments. It has documented safety with a low incidence of side effects. It requires minimal dose adjustments.
The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). In patients with ischemic cerebral stroke (IS) or hemorrhage (ICH), intravenous infusion of large volume can contribute to cerebral edema or increase in intracranial pressure (ICP). If the infusion of nicardipine can be double or triple concentrated without the need of a central line, it not only offers titratable BP control, but also less overall volume to infuse the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Males or females, 18 years of age or older.
- •Acute ischemic cerebral stroke (IS) with uncontrollable hypertension that may need to be controlled for the purpose of considering thrombolytic therapy or anticoagulation therapy.
- •Intracerebral hemorrhagic (ICH) stroke patients, including subarachnoid hemorrhage (SAH) (surgically treated or not), any territory with an appropriate study (head CT scan or MRI scan) providing results consistent with this diagnosis, who may require the control of hypertension or control of blood pressure.
排除标准
- •Allergy to Nicardipine or known hypersensitivity to Nicardipine.
- •Chronic renal failure or Creatinine blood sample levels> 2.
- •Impaired hepatic function defined as a two times value of liver enzymes.
- •Severe left ventricular dysfunction defined as ventricular ejection fraction < 30%.
- •Patients or authorized representative who refused be enrolled into this study.
- •Advanced aortic stenosis.
- •Pregnant or nursing women will not be enrolled in this study.
- •No patient will be allowed to be enrolled in this study more than once.
- •Patients may not be enrolled into other clinical studies during their involvement with this study.
结局指标
主要结局
• Demonstrate the feasibility and safety of double and triple concentrated peripheral intravenous Nicardipine for patients in the Neuroscience Critical Care Unit.
次要结局
- Time and dosage adjustment needed to reach the target BP range
- Safety
- To evaluate the tolerance of the double or triple concentrated Nicardipine