Comparison of Two Intravenous Lipid Emulsions in Home Parenteral Nutrition Patients

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Total Parenteral Nutrition (TPN) is a way of feeding a person intravenously, and is required when the gastrointestinal tract is not able to function properly. TPN contains carbohydrates, protein, and fat and lipids. It also contains minerals and vitamins. The lipid that is currently used at the University Health Network home TPN program is Intralipid20%, which is based on Soybean oil, contains polyunsaturated fats and is a good source of energy and essential fatty acids, including omega 3 and 6 fatty acids, which needed by the body. However, long term use on Intralipid20% has been shown to have negative effects on antioxidant status, inflammation, liver, and the immune system.

SMOFlipid20% is a lipid emulsion that has been designed to maximize the ratio of omega 3 to omega 6 fatty acids, in an effort to avoid potentially harmful effects associated with Intralipid20%. In previous studies, it has been shown that SMOFlipid20% is safe and has positive benefits on the liver enzymes. There are no studies so far which follow patient who is on SMOFlipid20% long term. The investigators hope to show that with long term use of SMOFlipid20% is better for liver function compared to Intralipid20%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johane Allard
• Treatments: Fat Emulsions, Intravenous; SMOFlipid; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• Signed and dated informed consent form (ICF) to participate before any study related procedures are performed

• Adult over the age of 18

• Both males and females

• Clinically stable for at least 4 weeks with no acute medical co-morbidities

• Patients on a stable Intralipid HPN regimen for 6 months and expected to require long-term PN for at least 13 more months

Exclusion Criteria:

Subjects not already on Intralipid PN Inability to give informed consent Alcohol or drug abuse Pregnant and lactating women

Clinical instability such as the following:

• Acute pulmonary edema

• Decompensated heart failure

• Decompensated chronic liver disease

• Severe post-traumatic conditions

• Uncontrolled diabetes mellitus

• Acute myocardial infarction

• Acute stroke

• Acute thromboembolism

• Metabolic acidosis

• Sepsis

• Hypotonic dehydration

• Coagulopathy with prolonged aPTT or INR Elevated triglyceride level: more than 4.5 mmol/L Active malignancy with life expectancy less than one year Subjects who are hypersensitive or allergic to the product ingredients of SMOF or Intralipid, including soybean oil, peanuts, fish oil, and egg as well as allergy to peanuts.