Comparison of Two Intravenous Lipid Emulsions in Home Parenteral Nutrition Patients
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|ClinicalTrials.gov Identifier: NCT02796833|
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : April 19, 2019
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%.
|Condition or disease||Intervention/treatment||Phase|
|Home Parenteral Nutrition||Drug: SMOFlipid20%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Controlled Trial Comparing Two Commercially Available Lipid Emulsions in Patients Receiving Home Parenteral Nutrition - SMOF Versus Intralipid|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Patients that are randomized to receive for the first 6 months SMOF as a lipid emulsion in their PN, and for the next 6 month (after 28 days of active washout on Intralipid) Intralipid, which is the standard lipid emulsion used in the hospital. SMOF is approved by Health Canada.
The parenteral nutrition bags are compounded individually for each patient based on their specific needs.
Patients that are randomized to receive Intralipid, which is the standard lipid emulsion used in the hospital for the first 6 months, and for the next 6 month (after 28 days of active washout on Intralipid) SMOF as a lipid emulsion in their PN. SMOF is approved by Health Canada.The parenteral nutrition bags are compounded individually for each patient based on their specific needs.
- change in alanine transaminase (ALT) [ Time Frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months ]
- changes in liver function tests (total and conjugated bilirubin, ALP, AST, GGT) [ Time Frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months ]
- rate of infections (central line and other) per 1000 catheter days [ Time Frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months ]
- antibiotic days for acute infections [ Time Frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months ]
- number of hospitalizations for the past 6 months [ Time Frame: baseline 1, 6 months, 13 months ]
- number of catheter changes for the past 6 months [ Time Frame: baseline 1, 6 months, 13 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796833
|Contact: Katherine Schwenger, PhD, RDemail@example.com|
|Contact: Olivia Saqui, RN||+1-416-340-4018||Olivia.Saqui@uhn.ca|
|Toronto General Hospital, University Health Network||Recruiting|
|Toronto, Ontario, Canada|
|Principal Investigator:||Johane Allard, MD, FRCPC||University Health Network, Toronto|