SMOFLipid in Patients Who Are Intralipid Intolerant

Mayo Clinic

Status and phase

Withdrawn

Phase 4

Conditions

Home Parenteral Nutrition

Short Bowel Syndrome

Treatments

Drug: Standard therapy

Drug: SMOFLipid

Study type

Interventional

Funder types

Other

Identifiers

NCT03054948

16-009516

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.