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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
Sponsor:
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto

Brief 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%.


Condition or disease Intervention/treatment Phase
Home Parenteral Nutrition Drug: SMOFlipid20% Phase 4

Detailed Description:
A prospective double-blind, crossover, randomized clinical trial of 13 months duration per participant to compare between 2 commercially available lipid emulsion, Intralipid vs SMOF, in patient receiving home parenteral nutrition (HPN). All subjects are stable HPN patients who receive Intralipid as lipid emulsion in their solutions. The subjects will be randomized to two groups. One group will receive Intralipid for 6 months, followed by 28 days of wash-out period, and then will receive SMOF for 6 months. Another groups will receive SMOF in first 6 months, followed by 28 days of wash-out period, then will receive Intralipid for 6 months. During wash-out period for both groups, the patients will receive Intralipid as standard lipid emulsion. Each patient will have 4 clinic visits at Toronto General Hospital for clinical interview, nutritional measurements, routine blood tests, and special blood tests at baseline then at 6, 7, 13 months. Also, the patients will be asked to have routine blood tests after month 3 and month 9. The patients will fill the food record which will be collected later after completion of each period, month 6 and 13 of the study. The investigators will be calling patients during both periods to check compliance and update on their condition including the adverse events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SMOF/Intralipid

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.

Drug: SMOFlipid20%
Intralipid/SMOF
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.
Drug: SMOFlipid20%



Primary Outcome Measures :
  1. change in alanine transaminase (ALT) [ Time Frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months ]

Secondary Outcome Measures :
  1. changes in liver function tests (total and conjugated bilirubin, ALP, AST, GGT) [ Time Frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months ]
  2. rate of infections (central line and other) per 1000 catheter days [ Time Frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months ]
  3. antibiotic days for acute infections [ Time Frame: baseline 1, 6 months, baseline 2 (7 mo), 13 months ]
  4. number of hospitalizations for the past 6 months [ Time Frame: baseline 1, 6 months, 13 months ]
  5. number of catheter changes for the past 6 months [ Time Frame: baseline 1, 6 months, 13 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Katherine Schwenger, PhD, RD +1-416-340-4413 kschweng@uhnresearch.ca
Contact: Olivia Saqui, RN +1-416-340-4018 Olivia.Saqui@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital, University Health Network Recruiting
Toronto, Ontario, Canada
Sponsors and Collaborators
Johane Allard
Investigators
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Principal Investigator: Johane Allard, MD, FRCPC University Health Network, Toronto

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Responsible Party: Johane Allard, Professor of Medicine, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02796833     History of Changes
Other Study ID Numbers: 14-8537-A
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johane Allard, University Health Network, Toronto:
Home parenteral nutrition
Liver injury
Intravenous Lipid Emulsions
Catheter-related infections
Safety

Additional relevant MeSH terms:
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Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions