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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

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

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

NCT ID

NCT03773237

First Posted

November 12, 2018

Last Updated

May 30, 2023

Sponsor

Mayo Clinic

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

Studies a U.S. FDA-regulated Device Product

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

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

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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