Comparison of Two Intravenous Lipid Emulsions in Home Parenteral Nutrition Patients

Sponsor

Johane Allard (Other)

Overall Status

Completed

CT.gov ID

NCT02796833

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2016

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: 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%
Other: 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%

Arm

Intervention/Treatment

Other: 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%

Other: 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%

Outcome Measures

Primary Outcome Measures

change in alanine transaminase (ALT) [baseline 1, 6 months, baseline 2 (7 mo), 13 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.