Efficacy, Safety and Quality of Life of a Long-term Home Parenteral Nutrition Regimen With Either LIPIDEM® or LIPOFUNDIN® MCT a Mono-center, Randomized, Double Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI
研究概览
简要总结
It is the purpose of this trial to provide evidence for safety and efficacy of long term home parenteral nutrition with either Lipofundin MCT or Lipoplus in patients with proven insufficient enteral resorption.
详细描述
Long term parenteral nutrition is indicated in the home care setting of patients who are unable to completely cover their daily caloric requirements by oral/enteral nutrition due to e.g. pre existing malnutrition or compromised intestinal absorption.
An appropriate nutritional supplementation ensuring the provision of patients basic requirement of amino acids, glucose, lipids, micronutrients and electrolytes is therefore required to stop weight loss, increase quality of life and to reduce unfavorable consequences of malnutrition in those patients.
Major causes for malnutrition and compromised intestinal absorption are malignant processes. Tumor cachexia, weight loss due to insufficient nutrition of < 60 -80 % of the calculated substrate need for > 14 days, antineoplastic therapy and surgical intervention are consequences of the malignant disease and lead to catabolic processes.
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
- Double (Participant, Investigator)
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
- •Signed informed consent
- •Age: 18-80 years
- •Male and female patients
- •Patients with a newly indicated need of long-term home parenteral nutrition (HPN) for at least 8 weeks
- •Patients with an insufficient resorption capacity of the colon that may not be compensated by enteral nutrition
- •mentally and physically able to adhere to study procedures.
- •Females agree to apply adequate contraception
排除标准
- •Participation in a clinical study with an investigational drug within one month prior to the start of study
- •Patients with sepsis, severe sepsis and septic shock
- •Known or suspected drug abuse
- •General contra indications for infusion therapy such as acute pulmonary edema, hyperhydration and decompensated cardiac insufficiency
- •Pregnancy and lactation
- •Autoimmune disease as e.g. HIV
- •Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
- •Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
- •Alterations of coagulation (thrombocytes <150.000 mm3), PT < 50%, PTT > 40 sec
- •Diabetes mellitus with known ketoacidosis within 7 days before onset of study
- •Renal insufficiency with serum creatinine > 1.4 mg/dL(>124 mmol/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 (>2.86 mmol/L)
- •necrotizing pancreatitis
研究组 & 干预措施
1
treatment with Lipoplus & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
干预措施: Lipoplus (Drug)
2
treatment with Lipofundin MCT & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
干预措施: Lipofundin MCT (Drug)
结局指标
主要结局
Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI
时间窗: 8 weeks
次要结局
- Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition(8 weeks)