NCT01303250终止4 期
Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery
University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年4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
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Total amount of administered fluids
研究概览
简要总结
The primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation <= 12%.
The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.
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
- Quadruple (Participant, Care Provider, 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
- •patients undergoing elective colorectal surgery
- •minimum age 18 years
- •informed consent
排除标准
- •patients with severe cardiomyopathy or severe heart failure
- •history of coagulation disorders
- •intracranial hemorrhage
- •patients with severe cardiovascular or respiratory disorders
- •renal insufficiency
- •severe liver diseases
研究组 & 干预措施
Group 1
Experimental
A balanced hydroxyethyl starch 130/0.4 will be used
干预措施: balanced 6% hydroxyethylstarch 130/0.4 (Drug)
Group 2
Active Comparator
A balanced crystalloid will be used
干预措施: balanced crystalloid (Drug)
结局指标
主要结局
Total amount of administered fluids
时间窗: intraoperatively
Total amount of administered fluids intraoperatively that is necessary to keep patients optimal hemodynamic stabilized
次要结局
- Incidence of surgery related complications(day 28 and 90 postoperatively)
研究者
研究点 (1)
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