Crohn Disease Clinical Trial
Official title:
Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.
Verified date | April 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Direct Bilirubin Change is assessed | mg/dL | At 12 weeks weeks |
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