NCT01553617已完成4 期
Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 5
- 主要终点
- Calculated red blood cell loss
研究概览
简要总结
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
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
- None
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
- •male or female adult patients
- •undergoing primary elective cardiac surgery applying extracorporeal circulation
- •signed written informed consent
排除标准
- •known contraindication against scheduled medication
- •pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation
- •planned systemic hypothermia (body temperature < 30°C)
- •expected time on ECC ≥ 2 hours
研究组 & 干预措施
Volulyte
Experimental
6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
干预措施: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) (Drug)
Human serum albumin
Active Comparator
Human serum albumin (HSA 50g/L)
干预措施: Human serum albumin (Drug)
结局指标
主要结局
Calculated red blood cell loss
时间窗: up to 3rd postoperative day
次要结局
- Haemodynamics(up to 3rd postoperative day)
- Fluid input/output(up to 3rd postoperative day)
- Use of vasoactive and inotropic drugs(up to 3rd postoperative day)
- Laboratory parameters(up to 3rd postoperative day)
研究者
研究点 (5)
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