NCT01174719已完成4 期
Phase 4 Study Comparing Albumin 5%, Hydroxyethylstrach 130/0.4 (6%) and Ringer Lactate for Volume Replacement During Cardiac Surgery
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
- 240
- 试验地点
- 1
- 主要终点
- chest tube drainage
研究概览
简要总结
The aim of the study is to compare three different regimens for volume replacement during cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL).
Main Outcome parameters: chest tube drainage and coagulation parameters. The investigators hypothesis is that HES is as safe as Albumin, however less expensive. Whether RL is an even less expensive and as safe alternative has to be shown.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Valve replacement
- •Coronary bypass surgery
排除标准
- •Severe left ventricular dysfunction
- •Coagulation disorders
研究组 & 干预措施
Ringer lactate
Active Comparator
干预措施: volume replacement (Drug)
Humanalbumin
Active Comparator
干预措施: Humanalbumin 5% (Drug)
Hydroxyethylstarch
Active Comparator
干预措施: volume replacement (Drug)
结局指标
主要结局
chest tube drainage
时间窗: 24 hours
次要结局
- Hemoglobin concentration(24 hours after surgery)
- platelet count(24 hrs after surgery)
- Hematocrit value(24 hours after surgery)
- activated clotting time(30 minutes after arrival ICU)
- Modified thromboelastometry coagulation analysis (ROTEM, Pentapharm, Munich, Germany)(24 hrs after surgery)
研究者
Eva M. Base
Associate Professor
Medical University of Vienna
研究点 (1)
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