SMOFLipid in Patients Who Are Intralipid Intolerant

NCT ID: NCT03054948

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-03-20

Brief Summary

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.

Conditions

Home Parenteral Nutrition; Short Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SMOFLipid

Patients in this arm with be randomized to SMOFlipid as their lipid emulsion

Group Type: EXPERIMENTAL

SMOFLipid

Intervention Type: DRUG

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

Standard therapy

Patients in this arm will be continue with their current lipid emulsion

Group Type: ACTIVE_COMPARATOR

Standard therapy

Intervention Type: DRUG

In most cases standard therapy will be IntraLipid.

Interventions

SMOFLipid

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

Intervention Type: DRUG

Standard therapy

In most cases standard therapy will be IntraLipid.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Manpreet S. Mundi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manpreet S Mundi

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

16-009516

Identifier Type: -

Identifier Source: org_study_id