Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemodynamic tolerance during treatment: defined by a stable mean blood pressure of 100-120
研究概览
简要总结
The aim of this study is to evaluate the tolerance of intravenous milrinone combined to the current standard treatment for cerebral vasospasm following subarachnoid hemorrhage. Assessment of IV milrinone safety in this setting is mandatory before the conduction of a large study assessing its effectiveness.
详细描述
The aim of this prospective observational study is to evaluate the hemodynamic tolerance of intravenous milrinone for the treatment of arterial vasospasm following subarachnoid hemorrhage. Intravenous milrinone is part of our standard care protocol for the management of cerebral vasospasm in association with nimodipine (intravenous or enteral route) and high arterial blood pressure (mean arterial pressure of 100-120 mmHg, spontaneously or induced by volume expansion and norepinephrine). All patients of our ICU who were diagnosed with cerebral arterial vasospasm during the few days following a subarachnoid hemorrhage will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subjects 18 years
- •Hospitalized in our intensive care unit
- •Subarachnoid hemorrhage proven on CT angiogram
- •Cerebral vasospasm proven on CT angiogram
排除标准
- •Pregnant women
- •Major under guardianship
结局指标
主要结局
Hemodynamic tolerance during treatment: defined by a stable mean blood pressure of 100-120
时间窗: At 6 months.
A good hemodynamic tolerance is defined by a stable mean blood pressure of 100-120 mmHg without neither the need to decrease milrinone infusion rate below 0.5 g.kg-1.min-1 nor the need to increase norepinephrine above 1g.kg-1.min-1 Safety Issue: No
次要结局
- Hematological tolerance: will be considered good if milrinone infusion was not interrupted(Hematological tolerance will be assessed daily through measuring platelet count for the duration of treatment.)
- Milrinone efficiency on patient-centered neurological outcome using the modified Rankin scale(At 6 months.)
- Rhythmic tolerance: defined by the occurrence of arrhythmia prompting the initiation of(Rhythmic tolerance will be assessed for the duration of treatment, which will be on average one month.Heart rate and rhythm will be measured continuously, but assessed for fluctuation outside the reference range daily (during the length of treatment).)
- Milrinone efficiency on cerebral vasospasm(Milrinone efficiency on cerebral vasospasm will be assessed for the duration of treatment, which will be on average one month. Mean velocity and the lindegard index will be initially measured at 0, 2, 12 and 24 hours; and subsequently daily.)