NCT00797589已完成4 期
Effect of Prime Solution on Fluid Balance After Open Heart 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
- 35
- 试验地点
- 1
- 主要终点
- fluid balance
研究概览
简要总结
The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.
详细描述
Fifty patients scheduled for elective primary and single cardiac surgery include in this prospective study. Patients with preoperative coagulation disorders, or renal or hepatic failure, are excluded.
Before admission to the operation theatre, the patients allocate in random order to receive one of the following solutions during the extracorporeal circulation:
- Ringer-acetate solution
- 6% HES solution (Tetraspan®) During the 1 postoperative day we register hemodynamic changes, fluid balance, fluid extravasation, plasma ion concentration, modified thromboelastography, and kidney 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
- Double (Investigator, Outcomes Assessor)
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
- •Elective combined cardiac surgery
排除标准
- •Liver failure
- •Kidney failure
研究组 & 干预措施
HES solution (Tetraspan®)
Experimental
Balanced colloid solution
干预措施: HES (Drug)
Ringer lactate
Experimental
Crystalloid solution
干预措施: Ringer lactate (Drug)
结局指标
主要结局
fluid balance
时间窗: 1 postoperative day
次要结局
未报告次要终点
研究者
Alexey Schramko
MD, PhD
University of Helsinki
研究点 (1)
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