SMOFLipid in Patients Who Are Intralipid Intolerant

Mayo Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Home Parenteral Nutrition Short Bowel Syndrome

Interventions

SMOFLipidDRUG

SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.

Standard therapyDRUG

In most cases standard therapy will be IntraLipid.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

AST

Primary aim is to assess impact on AST (liver enzyme)

Time frame: 3-12 months

Glucose

blood glucose

Time frame: 3-12 months

Triglycerides

blood triglycerides

Time frame: 3-12 months

ALT

liver enzyme

Time frame: 3-12 months

Total bilirubin

Liver study

Time frame: 3-12 months

CRP

inflammatory marker

Time frame: 3-12 months

Data from ClinicalTrials.gov

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