Intralipid Versus SMOFlipid in HPN Patients

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03773237

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Short Bowel Syndrome Intestinal Fistula Crohn Disease Intestinal Obstruction	Dietary Supplement: SMOFLipid Dietary Supplement: Intralipid	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective Randomized ControlledProspective Randomized Controlled

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Dec 31, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SMOFLipid SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.	Dietary Supplement: SMOFLipid SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
Active Comparator: IntraLipid Intralipid is a lipid emulsion that contains soybean oil	Dietary Supplement: Intralipid Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid

Arm

Intervention/Treatment

Active Comparator: SMOFLipid

SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.

Dietary Supplement: SMOFLipid

SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.

Active Comparator: IntraLipid

Intralipid is a lipid emulsion that contains soybean oil

Dietary Supplement: Intralipid

Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid

Outcome Measures

Primary Outcome Measures

Direct Bilirubin Change is assessed [At 12 weeks weeks]
mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.