Clinical Study Comparing Safety and Efficacy of SMOFlipid, the New Generation Fat Emulsion, in Comparison With the Current Fat Emulsion Lipovenoes MCT at the Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evidence for immunoregulatory effect of lipid emulsion products.
研究概览
简要总结
Comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.
详细描述
The comparison of two lipid emulsion product will be performed. Patients who plan to accept gastrectomy will be consider for trial and signed content will be obtained. If the patient needs total parenteral nutrition (TPN) treatment after surgery for at least 5 days and meets all criteria, then he/she will be enrolled and randomized to ether of the groups, SMOFlipid or Lipovenoes MCT. During the treatment period, efficacy variables and safety variables will be measured. Life quality evaluation will also be performed through questionnaires collection.
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
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 25 ~ 75 years old
- •Postoperative (gastrectomy) patients required parental nutrition for at least 5 days
- •Signed informed consent form
排除标准
- •Known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients
- •Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia. If the fasting S-triglyceride value at the time of inclusion is >2.26 mmol/l (>200 mg/dl) the subject must not be included
- •Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.)
- •Severe renal insufficiency with need for dialysis, chronic stable renal insufficiency defined as S-creatinine value of >3mg/dL (250 µmol/l), or dialysis/hemofiltration therapy
- •Over weight (BMI> 30kg/m2)
- •Severe blood coagulation disorders
- •Inborn abnormality in amino acid metabolism
- •Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration)
- •Known diabetic ketoacidosis 7 days prior to randomization.
- •Acute shock
- •General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
- •Pregnancy or lactation
- •Chemotherapy within 7 days before start of the trial
- •Participation in another clinical study with an investigational drug or an investigational medical device within 1 month prior to start of study or during the study
- •Already accept parental nutrition therapy.
研究组 & 干预措施
SMOFlipid
干预措施: lipid emulsion for TPN (Drug)
Lipovenoes MCT
干预措施: lipid emulsion for TPN (Drug)
结局指标
主要结局
Evidence for immunoregulatory effect of lipid emulsion products.
时间窗: 1-5 days after treatment provided
次要结局
未报告次要终点