NCT00936247终止4 期
Prospective, Controlled, Single-blind, Bicentric, Randomized Study on the Safety of HES 130/0.42 Combined With a Bal. Electr. Sol. vs 5% Albumin Comb. With an Unbal. Electr. Sol. (NaCl 0.9%) in Pat. With Compensated Renal Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Impact of two different volume replacement regimes on base excess in patients with reduced renal function
研究概览
简要总结
This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 80 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
HES 130/0.42 + Sterofundin ISO
干预措施: HES 130/0.42 + electrolyte solution (Drug)
2
Active Comparator
Albumin + NaCl 0.9%
干预措施: Albumin + electrolyte solution (Drug)
结局指标
主要结局
Impact of two different volume replacement regimes on base excess in patients with reduced renal function
时间窗: from pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up)
次要结局
- Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication(inta-/postoperative)
研究者
研究点 (2)
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