Status:
COMPLETED
Intralipid Versus SMOFlipid in HPN Patients
Lead Sponsor:
Mayo Clinic
Conditions:
Short Bowel Syndrome
Intestinal Fistula
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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
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, abil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03773237
Start Date
December 31 2018
End Date
October 1 2024
Last Update
May 16 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905