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Intralipid Versus SMOFlipid in HPN Patients

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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

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE December 31, 2018
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Direct Bilirubin Change is assessed [ Time Frame: At 12 weeks weeks ]
mg/dL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intralipid Versus SMOFlipid in HPN Patients
Official Title  ICMJE Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Short Bowel Syndrome
  • Intestinal Fistula
  • Crohn Disease
  • Intestinal Obstruction
Intervention  ICMJE
  • Dietary Supplement: SMOFLipid
    SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
  • Dietary Supplement: Intralipid
    Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid
Study Arms  ICMJE
  • Active Comparator: SMOFLipid
    SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.
    Intervention: Dietary Supplement: SMOFLipid
  • Active Comparator: IntraLipid
    Intralipid is a lipid emulsion that contains soybean oil
    Intervention: Dietary Supplement: Intralipid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Manpreet S Mundi, MD 507-284-4080 Mundi.Manpreet@mayo.edu
Contact: Vishakantha (Vishu) Murthy, PhD 507-255-8112 Murthy.Vishakantha@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773237
Other Study ID Numbers  ICMJE 17-001403
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Manpreet S. Mundi, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manpreet S Mundi, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP