Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- infective complications
研究概览
简要总结
The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.
详细描述
Postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count, biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°C pending analysis.
The primary endpoint was numbers of infective complications.Secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.
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
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition
排除标准
- •Metabolic disease
- •Chronic kidney or liver failure
- •Contraindications for lipid administration
- •PN during the 15 days before hospitalisation
研究组 & 干预措施
MCT/LCT
Structural Fat Emulsion Injection 250ml per day, for 7 days
干预措施: MCT/LCT (Drug)
MCT/LCT and fish oil
Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days.
干预措施: MCT/LCT and fish oil (Drug)
结局指标
主要结局
infective complications
时间窗: within the first 30 days after surgery
次要结局
- length of hospital stay(average of 2 weeks)
- plasma immunological markers(from 1 day before surgery to 7 days after surgery)
研究者
Wei Zhou
Attending
Sir Run Run Shaw Hospital