Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-Term Treatment With Parenteral Nutrition
Summary
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Parenteral Nutrition
Intervention
SMOF lipid and Intralipid
Location
North Shore Private Hospital
Saint Leonards
New South Wales
Australia
2065
Status
Active, not recruiting
Source
Fresenius Kabi
Results (where available)
Links
- 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.
Parenteral Nutrition
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).
Selenious Acid
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.
Clinical Trials
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The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until...
A Trial of Taurine Supplementation in Parenteral Nutrition 1
The purpose of this study is to investigate whether the inclusion of 1g of intravenous taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition associate...
The purpose of the study is to determine the tolerance on lipid metabolism and the safety of short-term parenteral nutrition as compared to enteral nutrition in critically ill patients wit...
PubMed Articles
To provide further evidence for the lipid sink theory, we have developed an in vitro model to assess the effect of Intralipid(®) 20% on methaemoglobin formation by drugs of varying lipid solubility....
Many patients in hospital are malnourished, either as a consequence of their disease or as its proximal cause. Various modalities are available for nutritional support, most of which use the enteral r...
Hair loss in long-term or home parenteral nutrition: are micronutrient deficiencies to blame?
PURPOSE OF REVIEW: To review the key nutritional factors associated with hair loss in long-term parenteral nutrition patients. RECENT FINDINGS: The phenomenon of unexplained hair loss is multifactoria...
The intrahepatic cholestasis attributed to parenteral nutrition (PN) in the adult patient is relatively rare and usually occurs in patients receiving long-term PN. This article reports the first case...
The provision of parenteral nutrition: it's not in the bag.
The administration of parenteral nutrition is a well-established technique providing nutritional support to patients who have an inaccessible or non-functioning gut (intestinal failure). As such it is...
