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Intralipid Versus SMOFlipid in HPN Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773237
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Manpreet S. Mundi, Mayo Clinic

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective 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 : December 31, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: 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




Primary Outcome Measures :
  1. Direct Bilirubin Change is assessed [ Time Frame: At 12 weeks weeks ]
    mg/dL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773237


Contacts
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Contact: Manpreet S Mundi, MD 507-284-4080 Mundi.Manpreet@mayo.edu
Contact: Vishakantha (Vishu) Murthy, PhD 507-255-8112 Murthy.Vishakantha@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Manpreet Mundi, MD    507-284-4080    Mundi.Manpreet@mayo.edu   
Contact: Vishakantha Murthy, PhD    507-255-8112    Murthy.Vishakantha@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Manpreet S Mundi, MD Mayo Clinic

Additional Information:
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Responsible Party: Manpreet S. Mundi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03773237    
Other Study ID Numbers: 17-001403
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manpreet S. Mundi, Mayo Clinic:
SMOF
Intralipid
Mixed oil emulsion
Intestinal failure
HPN
Additional relevant MeSH terms:
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Crohn Disease
Short Bowel Syndrome
Intestinal Obstruction
Intestinal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Malabsorption Syndromes
Postoperative Complications
Pathologic Processes
Digestive System Fistula
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions