SMOFLipid in Patients Who Are Intralipid Intolerant

Study Overview
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Brief Summary
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Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.

Official Title
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Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.

Conditions
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Home Parenteral Nutrition, Short Bowel Syndrome

Intervention / Treatment
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* Drug: SMOFLipid
* Drug: Standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years current Mayo Clinic HPN patient, able to provide informed consent, anticipated duration of HPN greater than 3 months infusion company is able to provide SMOFlipid no history of alcohol addiction noted to be intolerant to SO based IVFE as defined below. Exclusion Criteria: Pregnant women failure to provide consent patients who are deemed to be on HPN for less than three months patients who have previous proven addiction and dependence to alcohol/ heavy alcohol consumption reported (during history or reported in the EMR), known hypersensitivity to fish, egg, or soy, patients who will not be managed by the Mayo Clinic HPN team and patients who have active infection (as determined by the clinician) at the time of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMOFLipid<br>Patients in this arm with be randomized to SMOFlipid as their lipid emulsion | Drug: SMOFLipid<br>* SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.<br>|
| Active Comparator: Standard therapy<br>Patients in this arm will be continue with their current lipid emulsion | Drug: Standard therapy<br>* In most cases standard therapy will be IntraLipid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AST | Primary aim is to assess impact on AST (liver enzyme) | 3-12 months | 
| Glucose | blood glucose | 3-12 months | 
| Triglycerides | blood triglycerides | 3-12 months | 
| ALT | liver enzyme | 3-12 months | 
| Total bilirubin | Liver study | 3-12 months | 
| CRP | inflammatory marker | 3-12 months |