Intralipid Versus SMOFlipid in HPN Patients



Status:Recruiting
Conditions:Hospital, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:18 - 75
Updated:1/13/2019
Start Date:December 31, 2018
End Date:May 1, 2022
Contact:Manpreet S Mundi, MD
Email:Mundi.Manpreet@mayo.edu
Phone:507-284-4080

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Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.

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.

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 2 weeks in the last 12 months prior
to enrollment.

- Patients who have been on TPN greater than 2 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.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-4080
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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