|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
22 April 2024 |
|
Main ID: |
NCT03773237 |
|
Date of registration:
|
12/11/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Intralipid Versus SMOFlipid in HPN Patients
|
|
Scientific title:
|
Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients. |
|
Date of first enrolment:
|
December 31, 2018 |
|
Target sample size:
|
22 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03773237 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Manpreet S Mundi, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mayo Clinic |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Crohn Disease
|
|
Intestinal Fistula
|
|
Short Bowel Syndrome
|
|
Intestinal Obstruction
|
|
Intervention(s)
|
|
Dietary Supplement: SMOFLipid
|
|
Dietary Supplement: Intralipid
|
|
Primary Outcome(s)
|
|
Direct Bilirubin Change is assessed
[Time Frame: At 12 weeks weeks]
|
|
Secondary ID(s)
|
|
17-001403
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|