Deaths in preterm infants after infusion of intravenous fat emulsions have been reported in the medical literature.1,2 Autopsy findings included intravascular fat accumulation in the lungs. Treatment of premature and low birth weight infants with intravenous fat emulsion must be based upon careful benefit-risk assessment. Strict adherence to the recommended total daily dose is mandatory; hourly infusion rate should be as slow as possible in each case and should not in any case exceed 1 g/kg in four hours. Premature and small for gestational age infants have poor clearance of intravenous fat emulsion and increased free fatty acid plasma levels following fat emulsion infusion; therefore, serious consideration must be given to administration of less than the maximum recommended doses in these patients in order to decrease the likelihood of intravenous fat overload. The infant’s ability to eliminate infused fat from the circulation must be carefully monitored (such as triglyceride and/or plasma free fatty acid levels). The lipemia must clear between daily infusions.
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LIPOSYN III SUMMARY
Liposyn III 30% (Intravenous Fat Emulsion) is a sterile, nonpyrogenic fat emulsion for intravenous administration. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program.
Liposyn III 30% Pharmacy Bulk Package is indicated for use in a pharmacy admixture program for the preparation of 3-in-1 or total nutrient admixtures (TNAs).
Liposyn III (intravenous fat emulsion) is indicated as a source of calories for patients requiring parenteral nutrition. Where such nutrition is required for extended periods of time (more than 5 days), Liposyn III is also indicated as a source of essential fatty acids to prevent or reverse biochemical changes in fatty acid composition of plasma lipids (elevated triene/tetraene ratio) and the clinical manifestations of EFAD.
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NEWS HIGHLIGHTS
Published Studies Related to Liposyn III (Intravenous Fat Emulsion)
A double-blind randomized study comparing the efficacy and safety of a composite
vs a conventional intravenous fat emulsion in postsurgical gastrointestinal tumor
patients. [2012]
and tolerance in surgical gastrointestinal (GI) tumor patients... CONCLUSIONS: composite IVFE was comparable with conventional LCT/MCT IVFE in
Effects of oral and intravenous fat load on blood pressure, endothelial function, sympathetic activity, and oxidative stress in obese healthy subjects. [2010.12]
We compared the effects of high and low oral and intravenous (iv) fat load on blood pressure (BP), endothelial function, autonomic nervous system, and oxidative stress in obese healthy subjects. Thirteen obese subjects randomly received five 8-h infusions of iv saline, 20 (32 g, low iv fat) or 40 ml/h intralipid (64 g, high iv fat), and oral fat load at 32 (low oral) or 64 g (high oral)...
Rapid cellular enrichment of eicosapentaenoate after a single intravenous injection of a novel medium-chain triacylglycerol:fish-oil emulsion in humans. [2010.04]
BACKGROUND: Dietary deficiency in n-3 (omega-3) polyunsaturated fatty acids (PUFAs) prevails in Western populations and potentially results in adverse health outcomes. To circumvent the slow n-3 PUFA incorporation in phospholipids of key cells after oral supplementation, a new preparation for intravenous bolus injection was developed with 20 g triacylglycerols/100 mL of a mixture of 80% medium-chain triacylglycerols (MCTs) and 20% fish oil (FO) (wt:wt), and 0.4 g alpha-tocopherol/100 mL of the same mixture. OBJECTIVE: Our objective was to document the enrichment of n-3 PUFAs in leukocyte and platelet phospholipids after a bolus intravenous injection of MCT:FO in men... CONCLUSION: Bolus intravenous injection of a novel MCT:FO emulsion allows rapid enrichment of cells with n-3 PUFAs.
Olive oil-based intravenous lipid emulsion in pediatric patients undergoing bone marrow transplantation: a short-term prospective controlled trial. [2009.12]
BACKGROUND & AIMS: Parenteral nutrition (PN) is an important component of the supportive care of children undergoing bone marrow transplantation (BMT). The study aimed to assess short-term safety and metabolic effects of an olive oil-based (OO) lipid emulsion compared with a MCT/LCT (M/L) emulsion in the clinical setting of pediatric BMT... CONCLUSIONS: OO lipid emulsion was well tolerated, maintained essential fatty acids and peroxidation status, and generated a favorable plasma lipid profile. In this study short-term use of OO intravenous lipid emulsions was safe in children who needed PN support during BMT.
A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. [2009.09]
Hepatocellular carcinoma (HCC) is a major and often therapeutically frustrating oncological problem. A total of 100 patients with unresectable HCC were recruited and randomized to be treated with either transcatheter arterial chemoembolization (TACE) or systemic chemotherapy... In this setting, serum albumin level is a candidate marker for selection of cases who may benefit from this procedure.
Clinical Trials Related to Liposyn III (Intravenous Fat Emulsion)
Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies [Not yet recruiting]
Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common
devastating gastrointestinal diseases in premature infants. These infants often need
surgical intervention to remove the dead bowel and create temporary enterostomies, resulting
in short bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or
dysfunction to digest and absorb nutrients adequately.
These infants are often nourished primarily with parental nutrition (PN) which can lead to
many complications including PN-associated liver disease. However, with enteral feeding, the
remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral
fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty
acids (LCPUFA) being the most beneficial in promoting bowel adaptation.
Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation.
Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and
increase weight gain in some SBS infants. WThe investigators will soon have completed a
randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled "Early
Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with
Enterostomies". The preliminary data suggest that (a) by supplementing enteral ML/FO, we
were able to decrease the use of IL; (b) premature infants in the treatment group who
received ML/FO achieved higher enteral calorie (% of total calorie) intake before
reanastomosis and better weight gain (g/day) after reanastomosis than those who received
routine care in control group; and (c) the direct bilirubin level before reanastomosis
tended to be lower in the treatment group than the control group although the difference was
not statistically significant. Because the intervention consisted of both an increase in
enteral fat intake as well as a specific type of fat intake (i. e. FO), it is unclear whether
improved outcomes in the ML/FO group are attributable to FO's anti-inflammatory effects or
the increased fat intake. Therefore, the investigators have designed a next randomized
clinical trial to compare ML alone versus ML plus FO. We hypothesize that as compared to ML
alone, ML plus FO will result in decreased systemic inflammation, as indicated by blood
levels of inflammation-related proteins and indicators of oxidative stress.
Effects of Canola Oil on Blood Vessel Function in Peripheral Arterial Disease [Recruiting]
The fatty acid composition of canola oil will have beneficial acute and chronic effects on
vascular function in individuals with peripheral arterial disease.
Canola Oil Multicentre Intervention Trial (COMIT) [Recruiting]
The objectives of this study are to examine how the consumption of treatment oils (including
canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower
oil) influence endothelial function, inflammation, oxidation, body composition, and plasma
lipoprotein characterization.
The Effect of Different Macronutrients on Ileal Brake Activation [Recruiting]
The purpose of this study is to determine whether ileal infusion of casein and sucrose can
activate the ileal brake.
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders [Recruiting]
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral
Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to
prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of
standard intravenous fat emulsions have implicated in the development and progression of
PNAC.
In this study, neonates with congenital/acquired gastrointestinal disorders will be
randomized, in a unblinded fashion, to receive either the standard dose of an intravenous
omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion
throughout their entire hospital course in the neonatal intensive care unit. The primary
outcome will be the presence of cholestasis at 28 days or when full feeds are reached,
whichever is longer.
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Page last updated: 2013-02-10
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