NCT00798447已完成3 期
A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.
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
- 100
- 试验地点
- 2
- 主要终点
- reduction of pro inflammatory activity
研究概览
简要总结
Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients considered for major surgery for gastric and colorectal cancer
- •expected requirement for post operative PN or TPN of at least 7 days
- •possibility of PN/TPN provision 1 day prior to surgery
- •Age >18 years old and <80 years old
- •Hemodynamically stable
- •Written Informed consent
排除标准
- •Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to the start of study
- •Patients with sepsis, severe sepsis or septic shock
- •Known or suspected drug abuse
- •Intrahepatic cholestasis
- •General contraindications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency
- •Pregnancy (positive in urine) or lactation
- •Autoimmune disease e.g. HIV
- •Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients of the investigational products
- •Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
- •Alterations of coagulation (thrombocytes <150000 /mm3), PT < 50%, PTT > 40 sec
- •Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
- •Renal insufficiency with serum creatinine > 1.4 mg/dL (>124 µmol/L)
- •Patients with severe liver dysfunction with bilirubin >2.5 mg/dL (> 43 µmol/L)
- •Lipid disorders, in particular fasting serum triglycerides > 250 mg/dL (>2.85 mmol/L),
研究组 & 干预措施
lipid emulsion with n-3 FA
Experimental
干预措施: MLF 541 (Drug)
lipid emulsion without n-3 FA
Active Comparator
干预措施: Lipofundin MCT (Drug)
结局指标
主要结局
reduction of pro inflammatory activity
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (2)
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