NCT00359697Unknown1 期
Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 主要终点
- Reduction of ICP below treatment threshold (less than 20 mmHg)
研究概览
简要总结
The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.
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
- 否
入选标准
- •Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
- •Patient greater than or equal to 18 years of age
- •ICP monitor in place
- •ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
- •Patient or patient's legally authorized representative has provided written informed consent
排除标准
- •Patient less than 18 years of age
- •Lack of ICP monitoring
- •Patient received Mannitol prior to placement of ICP monitor
- •Baseline serum osmolarity of greater than 310 mOsm/L
- •Patient is currently enrolled in another investigational drug or device study
- •Congestive heart failure at time of enrollment
- •Chronic renal failure on hemodialysis
- •Pregnancy
结局指标
主要结局
Reduction of ICP below treatment threshold (less than 20 mmHg)
次要结局
- Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality
研究者
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