Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-Term Treatment With Parenteral Nutrition
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
SMOF lipid and Intralipid
North Shore Private Hospital
New South Wales
Active, not recruiting
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00451646
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Parenteral Nutrition Solutions
Specialized solutions for PARENTERAL NUTRITION. They may contain a variety of MICRONUTRIENTS; VITAMINS; AMINO ACIDS; CARBOHYDRATES; LIPIDS; and SALTS.
The administering of nutrients for assimilation and utilization by a patient who cannot maintain adequate nutrition by enteral feeding alone. Nutrients are administered by a route other than the alimentary canal (e.g., intravenously, subcutaneously).
Parenteral Nutrition, Home
The at-home administering of nutrients for assimilation and utilization by a patient who cannot maintain adequate nutrition by enteral feeding alone. Nutrients are administered via a route other than the alimentary canal (e.g., intravenously, subcutaneously).
A selenium compound used as a source of SELENIUM, especially for patients that develop selenium deficiency following prolonged PARENTERAL NUTRITION.
Parenteral Nutrition, Home Total
The at-home administering of nutrients for assimilation and utilization by a patient whose sole source of nutrients is via solutions administered intravenously, subcutaneously or by some other non-alimentary route.
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