Intralipid Versus SMOFlipid in HPN Patients

Overview

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

Full Title of Study: “Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 30, 2021

Detailed Description

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.

Interventions

  • Dietary Supplement: SMOFLipid
    • SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
  • Dietary Supplement: Intralipid
    • Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid

Arms, Groups and Cohorts

  • Active Comparator: SMOFLipid
    • SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.
  • Active Comparator: IntraLipid
    • Intralipid is a lipid emulsion that contains soybean oil

Clinical Trial Outcome Measures

Primary Measures

  • Direct Bilirubin Change is assessed
    • Time Frame: At 12 weeks weeks
    • mg/dL

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Manpreet S. Mundi, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Manpreet S Mundi, MD, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Manpreet S Mundi, MD, 507-284-4080, Mundi.Manpreet@mayo.edu

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