临床试验/NCT00662376

NCT00662376已完成不适用

Safety, Tolerance and Metabolic Effects of Using a Preoperative Oral Nutritional Supplement (PreOP Booster) in Gastrointestinal Surgery

Fresenius Kabi1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2008年4月最近更新: 2008年12月8日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Fresenius Kabi
入组人数: 40
试验地点: 1
主要终点: Gastrointestinal tolerance

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this pilot study is to obtain data on the safety, tolerance and metabolic effects of the oral nutritional supplement (PreOP Booster) given to patients prior to gastrointestinal surgery.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: Double (Participant, Investigator)

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

•elective laparoscopic cholecystectomy

排除标准

•bile duct stones
•conditions affecting gastric emptying
•severe, organ-specific disorders
•inherited metabolic disorders
•known intolerance against or allergy to any component of the investigational feeds

结局指标

主要结局

Gastrointestinal tolerance

时间窗: day 0 before and 6-8h after surgery

Metabolic parameters in serum, liver and muscle tissue

时间窗: on day -1, 0, 1, and 7

Safety parameters reflecting pathophysiological functions of the liver

时间窗: day -1, 0, 1, and 7

次要结局

Clinical parameters (infectious and non-infectious complications)(until day 7)

研究者

发起方

Fresenius Kabi

申办方类型

Industry

研究点 (1)

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