NCT02866604Unknown不适用
Comparison of an Isotonic Balanced Fluid, Sterofundin® , With 0.9% Saline in Traumatic Brain Injury(TBI)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- 30 day mortality
研究概览
简要总结
The main objective of this study is to compare the clinical outcomes of TBI patients receiving only Sterofundin or 0.9% saline as main fluid therapy.
详细描述
Study Design: Prospective single centre double-blind randomized controlled trial
Study endpoints/outcomes
Primary outcomes:
- 30 day mortality
- Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)
Secondary outcomes:
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients age between 18 and 65 years of age
- •Non-penetrating moderate (GCS 9-12) or severe (GCS 3-8) traumatic brain injury
- •Within 12 hours since the recorded time of injury
排除标准
- •Pregnancy
- •Polytrauma
- •Cardiac arrest at presentation
- •GCS of three with bilateral fixed dilated pupils,
- •Evidence of severe cardiac, respiratory, renal or liver dysfunction
结局指标
主要结局
30 day mortality
时间窗: 30 days
Functional neurological outcomes at 6 months based on Extended Glasgow Outcome Scale (GOS-E)
时间窗: 180 days
次要结局
- electrolyte balance(3 days)
- ICU mortality(30 days)
- Daily mean change in intracranial pressure (ICP)(3 days)
- Acid-base balance(3 days)
- Episodes of intracranial hypertension(3 days)
- Duration of mechanical ventilation(3 days)
- Length of ICU stay(30 days)
研究者
研究点 (2)
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