NCT01247740已完成3 期
A Prospective, Controlled, Randomized, Blinded, Parallel Group Multicentre Study on the Safety and Efficacy of a Convenience Three-chamber Bag for Parenteral Nutrition in Post-operative Patients After Abdominal Surgery Versus a Compounded Monobag
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Course of prealbumin (from day 1 to day 7)
研究概览
简要总结
The purpose of the study is to investigate the efficacy and safety of a convenient 3-chamber-bag containing aminoacids, glucose and lipid emulsion (LCT/MCT 20%) compared to a conventionally compounded monobag for parenteral nutrition.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 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
1
Experimental
three chamber bag for parenteral nutrition containing lipids, glucose, amino acids and electrolytes
干预措施: NuTRIflex Lipid peri (Drug)
2
Active Comparator
compounded monobag including lipids, glucose, amino acids and electrolytes
干预措施: compounded monobag (Drug)
结局指标
主要结局
Course of prealbumin (from day 1 to day 7)
时间窗: 7 days
次要结局
- clinical outcome parameters, haematology, liver function, blood biochemistry and electrolytes, coagulation function(7 days)
研究者
研究点 (1)
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