7.2% NaCl in 6% Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage (SAH) Patients.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period
研究概览
简要总结
The purpose of this study is to determine whether 7.2% NaCl in 6% hydroxyethyl starch will lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a placebo controlled study, and to describe the haemodynamic effects.
详细描述
In the acute phase after a SAH, many patients need intensive care treatment to control the development of fatally increased intracranial pressure. One type of treatment used is osmotherapy. Traditionally mannitol has been the preferred drug, but the use of hypertonic saline solutions has gained more and more acceptance. The immediate effect seems to be equivalent or better than with mannitol, and there seem to be less adverse effects, such as hypovolemia, acute renal failure, hyponatremia, and rebound increase of ICP.
Most clinical studies in patients with life-threatening increase in ICP are observational, and show a predictable effect of hypertonic saline. We wanted to strengthen our own findings from such a study by applying the same study model but with a placebo control group in patients with only moderately elevated ICP.
We also wanted to document the haemodynamic effects, measuring cardiac output, intrathorasic blood volume and extravascular lung water.
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
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
- •Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured
- •Age > 18 years
- •Mechanically ventilated
- •Stable hemodynamics
- •Stable intracranial pressure between 10 - 20 mmHg
排除标准
- •- Serum sodium > 160 mmol/l
结局指标
主要结局
Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period
次要结局
- Changes in cerebral perfusion pressure (CPP) measured as AUC
- changes in cardiac output
- intrathorasic blood volume
- extravascular lung water
- serum sodium levels during the 210 minutes trial period