Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Change in serum chloride
研究概览
简要总结
Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose of sterofundin solution given to healthy volunteer in the resuscitation manner compared with normal saline solution.
详细描述
10 healthy volunteers were randomly assigned to receive either normal saline or sterofundin for the first solution in dose of 30 mL/kg (max 2 L) over 1 hour. Blood was collected at baseline (T0), at 60 minutes (T1), 120 minutes (T2), and 240 minutes (T4) from baseline. Time to fist void after initiation of fluid and urine volume were also recorded. After wash-out period of at least 1 week, crossover studies were performed with another fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (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
- 是
入选标准
- •No underlying disease
- •LVEF > 0.5
- •No current medication usage
排除标准
- •Pregnancy or lactation
- •BMI <18 or >25
- •Fever presented in the past 2 weeks
研究组 & 干预措施
NSS
NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
干预措施: Sterofundin (Drug)
NSS
NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
干预措施: NSS (Drug)
Sterofundin
Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
干预措施: Sterofundin (Drug)
Sterofundin
Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
干预措施: NSS (Drug)
结局指标
主要结局
Change in serum chloride
时间窗: 4 hours
At 0, 1, 2, and 4 hours from initiation
次要结局
- Change in serum pH(4 hours)
- Change in serum osmolality(4 hours)
- Change in serum SID(4 hours)
- Time to first void(Within 24 hours)
- Urine volume(Within 24 hours)
研究者
Cherdkiat karnjanarachata
Dr.
Ramathibodi Hospital