NCT01176695已完成3 期
A Randomized, Double Blind, Controlled, Parallel Group, Multicenter Study on the Efficacy and Safety of a Fish Oil Containing Lipid Emulsion vs. a Medium and Long Chain Lipid Emulsion in Patients Undergoing Elective Abdominal Surgery of Moderate Severity
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
- 2
- 主要终点
- To investigate on the efficacy of fish oil on the nutrition status
研究概览
简要总结
The purpose of the study is to compare a fish oil containing lipid emulsion against a medium-chain/long-chain triglyceride (MCT/LCT) lipid emulsion in terms of their efficacy and safety during postoperative 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Patients considered for open abdominal surgery of moderate severity, e.g.. radical operation for stomach cancer or pancreaticoduodenal surgery
- •Male and female patients ≥18 and <85 years of age
- •Indication for total parenteral nutrition therapy: for at least 5 consecutive days after operation
- •Ability and willingness to give voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Review Board (IRB) prior to all evaluations, and to comply with the requirements of the study.
排除标准
- •General contraindications for parenteral nutrition (acidosis of various geneses, untreated disorders of electrolyte and fluid intake and output, inadequate cellular oxygen supply)
- •General contraindications for infusion therapy such as acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency
- •Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
研究组 & 干预措施
1
Experimental
fish oil containing lipid emulsion
干预措施: fish oil containing lipid emulsion (Drug)
2
Active Comparator
MCT/LCT containing lipid emulsion
干预措施: MCT/LCT containing lipid emulsion (Drug)
结局指标
主要结局
To investigate on the efficacy of fish oil on the nutrition status
时间窗: day 1 to day 6
Prealbumin as the primary endpoint variable
To investigate on the efficacy of fish oil on an inflammatory parameter
时间窗: day 1 to day 6
LTB5/LTB4 as a second primary endpoint
次要结局
- Incidence of postoperative complications(6 days)
- Liver function(6 days)
- Coagulation parameters(6 days)
- Blood chemistry(6 days)
- SIRS(6 days)
研究者
研究点 (2)
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