Crohn Disease, Intestinal Fistula, Intestinal Obstruction, Short Bowel Syndrome
Conditions
Keywords
SMOF, Intralipid, Mixed oil emulsion, Intestinal failure, HPN
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, ability to meet caloric needs through TPN, and ability to obtain appropriate macronutrient composition.
Interventions
DIETARY_SUPPLEMENTSMOFLipid
SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
DIETARY_SUPPLEMENTIntralipid
Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Intervention model description
Prospective Randomized Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Direct/Indirect Bilirubin Change is assessed | At 12 weeks weeks | mg/dL |
Countries
United States
Outcome results
None listed