NCT01301469已完成3 期
Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Maximum difference of the mean arterial blood pressure
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
6% HES 130/0.42 in plasma adapted Ringer's solution (balanced solution)
干预措施: 6% HES 130/0.42 in plasma adapted Ringer's solution (Drug)
2
Active Comparator
HES 130/0.4 in a saline solution
干预措施: 6% HES 130/0.4 in a saline solution (Drug)
结局指标
主要结局
Maximum difference of the mean arterial blood pressure
时间窗: 1 hour
次要结局
未报告次要终点
研究者
研究点 (3)
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