Intralipid Versus SMOFlipid in HPN Patients

Mayo Clinic

Status: Completed

Conditions: Intestinal Fistula; Short Bowel Syndrome; Intestinal Obstruction; Crohn Disease

Treatments: Dietary Supplement: SMOFLipid; Dietary Supplement: Intralipid

Study type: Interventional

Funder types: Other

Identifiers

NCT03773237

17-001403

Details and patient eligibility

About

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

Full description

Primary aim is to assess the impact to direct/indirect 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

SMOFLipid

Active Comparator group

Description:

SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.

Treatment:

Dietary Supplement: SMOFLipid

IntraLipid

Active Comparator group

Description:

Intralipid is a lipid emulsion that contains soybean oil

Treatment:

Dietary Supplement: Intralipid