SMOFLipid in Patients Who Are Intralipid Intolerant
| Status: | Withdrawn |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | February 1, 2017 |
| End Date: | March 20, 2018 |
Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.
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.
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.
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.
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