NCT01117649已完成4 期
Prospective, Controlled, Double-blind, Randomized Multi-centric Study on the Efficacy and Safety of a Target Controlled PVR Therapy With a Hyperoncotic Balanced Hydroxyethyl Starch (HES) Solution Versus an Isooncotic Balanced HES Solution Compared to a Balanced Electrolyte Solution in Elective 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
- 63
- 试验地点
- 3
- 主要终点
- First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)
研究概览
简要总结
The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.
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 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
2
Active Comparator
iso-oncotic colloid
干预措施: HES 6% (Drug)
1
Experimental
hyper-oncotic colloid
干预措施: HES 10% (Drug)
3
Active Comparator
crystalloid
干预措施: balanced electrolyte solution (Drug)
结局指标
主要结局
First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)
时间窗: up to 8 hours
Goal-directed (stroke volume) plasma volume therapy
Second endpoint: Time until fully on oral (solid) diet (days)
时间窗: up to 15 days
次要结局
- haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores(up to 7 days)
研究者
研究点 (3)
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