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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
42
i.v. fat emulsion for parenteral nutrition
i.V. fat emulsion for parenteral nutrition
Charité - Universitätsmedizin Berlin
Berlin, Germany
Proof of non-inferiority of a HPN regimen containing Lipidem compared to a Lipofundin MCT containing regimen as indicated by the BMI
Time frame: 8 weeks
Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition
Time frame: 8 weeks
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