A Study to Compare Intralipid Versus SMOFlipid in New Home Parenteral Nutrition (HPN) Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-001403
NCT ID: NCT03773237
Sponsor Protocol Number: 17-001403
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Manpreet Mundi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available