Safety and Efficacy of Longterm HPN With Two Lipid Emulsions
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||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|
- 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 ] [ Designated as safety issue: No ]
- Evaluation of beneficial effects of a long-term HPN-regimen with Lipidem on Quality of Life and body composition [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
treatment with Lipoplus & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
i.v. fat emulsion for parenteral nutrition
Active Comparator: 2
treatment with Lipofundin MCT & Nutriflex plus (commercially available and marketed 2 Chamber Bag)
Drug: Lipofundin MCT
i.V. fat emulsion for parenteral nutrition
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530738
|Charité - Universitätsmedizin Berlin|
|Berlin, Germany, 10117|
|Principal Investigator:||Paul Thul, MD||Charité, University Hospital Berlin|