Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

NCT ID: NCT00451646


Title
A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Purpose
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.
Details
Conditions
Parenteral Nutrition
Keywords
Source
Fresenius Kabi
Sponsors
Fresenius Kabi
Status
Completed
Acronym
Last Updated
25 Aug 2010
URL
Official Link
Locations
Australia, Denmark, France, Israel, Netherlands, Poland, United Kingdom