Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Total volume of intravenous hypertonic fluid administered to the patient
研究概览
简要总结
Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Able to consent
- •18 years or older
- •English speaking
- •Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration
排除标准
- •Fails to consent
- •< 18 years old
- •Hypertonic therapy not indicated
研究组 & 干预措施
Standard Therapy
This group will receive 3% hypertonic sodium chloride for the management of their cerebral edema. 3% Sodium Chloride is the generic name of this intravenous fluid preparation.
干预措施: 3% Sodium Chloride (Drug)
Balanced Therapy
This group will undergo two simultaneous infusions. 23.4% sodium chloride and 8.4% sodium bicarbonate will be infused at the same time in various ratios for management of cerebral edema with a balanced approach
干预措施: 23.4% Sodium Chloride (Drug)
Balanced Therapy
This group will undergo two simultaneous infusions. 23.4% sodium chloride and 8.4% sodium bicarbonate will be infused at the same time in various ratios for management of cerebral edema with a balanced approach
干预措施: 8.4% Sodium Bicarbonate (Drug)
结局指标
主要结局
Total volume of intravenous hypertonic fluid administered to the patient
时间窗: The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment
Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.
次要结局
- Urine output(Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment)
研究者
Tim Angelotti
Associate Professor of Anesthesiology
Stanford University