Intralipid Versus SMOFlipid in HPN Patients
Primary Purpose
Short Bowel Syndrome, Intestinal Fistula, Crohn Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SMOFLipid
Intralipid
Sponsored by
About this trial
This is an interventional supportive care trial for Short Bowel Syndrome focused on measuring SMOF, Intralipid, Mixed oil emulsion, Intestinal failure, HPN
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SMOFLipid
IntraLipid
Arm Description
SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.
Intralipid is a lipid emulsion that contains soybean oil
Outcomes
Primary Outcome Measures
Direct Bilirubin Change is assessed
mg/dL
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03773237
Brief Title
Intralipid Versus SMOFlipid in HPN Patients
Official Title
Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 31, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome, Intestinal Fistula, Crohn Disease, Intestinal Obstruction
Keywords
SMOF, Intralipid, Mixed oil emulsion, Intestinal failure, HPN
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Controlled
Masking
ParticipantCare ProviderInvestigator
Masking Description
The randomization list will be generated using http://www.randomization.com and blinded at enrollment using supplement codes. The study coordinator will hold the randomization codes and will be revealed to the investigators only after the statistical analysis is complete.
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMOFLipid
Arm Type
Active Comparator
Arm Description
SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.
Arm Title
IntraLipid
Arm Type
Active Comparator
Arm Description
Intralipid is a lipid emulsion that contains soybean oil
Intervention Type
Dietary Supplement
Intervention Name(s)
SMOFLipid
Intervention Description
SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intralipid
Intervention Description
Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid
Primary Outcome Measure Information:
Title
Direct Bilirubin Change is assessed
Description
mg/dL
Time Frame
At 12 weeks weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manpreet S Mundi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Intralipid Versus SMOFlipid in HPN Patients
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