Intralipid Versus SMOFlipid in HPN Patients

Crohn Disease Clinical Trial

Official title:

Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03773237
• Other study ID #: 17-001403
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 31, 2018
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Crohn Disease
• Fistula
• Intestinal Fistula
• Intestinal Obstruction
• Short Bowel Syndrome

Intervention

Dietary Supplement:
• SMOFLipid
SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
• Intralipid
Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct Bilirubin Change is assessed	mg/dL	At 12 weeks weeks