Intralipid Versus SMOFlipid in HPN Patients

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

Detailed Description
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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.

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

Conditions
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Short Bowel Syndrome, Intestinal Fistula, Crohn Disease, Intestinal Obstruction

Intervention / Treatment
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* Dietary Supplement: SMOFLipid
* Dietary Supplement: Intralipid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMOFLipid<br>SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil. | Dietary Supplement: SMOFLipid<br>* SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.<br>|
| Active Comparator: IntraLipid<br>Intralipid is a lipid emulsion that contains soybean oil | Dietary Supplement: Intralipid<br>* Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct Bilirubin Change is assessed | mg/dL | At 12 weeks weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SMOF, Intralipid, Mixed oil emulsion, Intestinal failure, HPN