NCT00576849已完成4 期
Phase 4 Study of a Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients
Klinikum Ludwigshafen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is postoperative renal function
研究概览
简要总结
A total balanced fluid replacement strategy is a promising concept for correcting hypovolemia. The effects of a balanced fluid management including a new balanced hydroxyethylstarch (HES) in elderly cardiac surgery patients will be studied.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >80 years
排除标准
- •Chronic kidney dysfunction requiring dialysis
- •Myocardial infarction within the previous 3 weeks
- •Liver insufficiency
研究组 & 干预措施
A
Experimental
Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid
干预措施: Balanced HES 130/0.42 (Drug)
B
Active Comparator
Conventional volume replacement strategy consisting of 6% HES 130/0.4 prepared in saline solution plus Ringer's lactate
干预措施: 6% HES 130/0.4 prepared in saline solution (Drug)
结局指标
主要结局
The primary endpoint of the study is postoperative renal function
时间窗: 28 days
次要结局
- Other organ function (myocardial function, endothelial function, degree of inflammation)(Postoperative period)
研究者
研究点 (1)
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