A Study to Compare Intralipid Versus SMOFlipid in New Home Parenteral Nutrition (HPN) Patients

Overview

About this study

The primary aim of the study will be to assess impact on direct bilirubin with the use of Intralipid versus Smoflipid.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subjects between ages of 18-75 years old.
  • 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 < 18 years.
  • Pregnant and lactating women.
  • Failure to provide consent.
  • Patients with underlying liver dysfunction (defined as liver function studies ≥ 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 > 1,000 mg/dL.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Manpreet Mundi, M.D.

Closed for enrollment

Contact information:

Osman Mohamed Elfadil M.B.B.S.

(507) 284-4080

MohamedElfadil.Osman@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20417137

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