Intralipid Versus SMOFlipid in HPN Patients

Clinical Trial ID: NCT03773237

Description

This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.

Primary aim is to assess the impact to direct bilirubin. Secondary aims will be to assess impact to other liver function studies, metabolic parameters, inflammatory marker, body weight, ability to meet caloric needs through TPN, and ability to obtain appropriate macronutrient composition.


Criteria

Inclusion Criteria: - Newly initiated Mayo Clinic HPN patient - Able to provide informed consent - Anticipated duration of HPN greater than 3 months, - Infusion company is able to provide Smoflipid Exclusion Criteria: - Age less than 18 years - Pregnant and lactating women - Failure to provide consent - Patients with underlying liver dysfunction (defined as liver function studies equal to or more than 2 times upper limit of normal) or pathology as determined by primary investigator - Patients with active malignancy - 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 AND consumption/active use reported during last 12 months. - Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients in Smoflipid - Patients who will not be managed by the Mayo Clinic HPN team - Patients who have active infection (as determined by the clinician) at the time of enrollment. - Patients who have received Smoflipid greater than 4 weeks in the last 12 months prior to enrollment. - Patients who have been on TPN greater than 4 weeks in the last 12 months prior to enrollment. - Enrolled in another interventional study. - Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides more than 1,000 mg/dL.

  • Start Date

    2018-12-31

  • Last Updated

    2020-01-17

  • Sponsor

    Mayo Clinic

  • Condition Name

    Crohn Disease

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