A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables
研究概览
简要总结
The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.
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
- •In- and out-patients in need of parenteral nutrition due to inability to sustain an adequate oral/enteral food intake for at least 4 weeks
- •Written consent from the subject
排除标准
- •Known hypersensitivity to fish-, egg-, soy-, or peanut-protein or to any of the active substances or excipients
- •Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia
- •Severe liver insufficiency
- •Severe blood coagulation disorders
- •Subjects with chronic stable renal insufficiency defined as S-creatinine value of > 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy
- •General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration
- •Unstable conditions
- •Unstable angina pectoris
- •Acute shock
- •Chemotherapy within 4 weeks before start of the trial
- •Chemotherapy during the trial
- •Subjects for whom the trial treatment is not appropriate
- •Female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum pregnancy test and must agree to maintain adequate birth control practice during the study.
- •Participation in another clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during the study
- •Prior inclusion in the present study
- •Any other feature that in the opinion of the investigator should preclude study participation
研究组 & 干预措施
2
Intralipid
干预措施: SMOF lipid and Intralipid (Drug)
1
SMOFlipid
干预措施: SMOF lipid and Intralipid (Drug)
结局指标
主要结局
Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables
时间窗: day 0, week 2, week 4
次要结局
未报告次要终点