Intralipid Versus SMOFlipid in HPN Patients

  • STATUS
    Recruiting
  • End date
    May 1, 2022
  • participants needed
    100
  • sponsor
    Mayo Clinic
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Updated on 17 February 2021
See if I qualify
lipid emulsion
smoflipid

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.

Details
Condition Intestinal Obstruction, Intestinal Diseases, Intestinal Fistula, Short Bowel Syndrome, Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), Bowel Dysfunction, crohns disease, bowel obstruction
Treatment Intralipid, SMOFLipid
Clinical Study IdentifierNCT03773237
SponsorMayo Clinic
Last Modified on17 February 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Crohn's Disease (Pediatric) or Bowel Dysfunction or Short Bowel Syndrome or Inflammatory bowel disease or Intestinal Obstruction or Intestinal Fistula...?
Do you have any of these conditions: Crohn's Disease or crohns disease or Crohn's Disease (Pediatric) or Intestinal Fistula or Intestinal Obstruction or Bowel Dysfunction or Short Bowel S...?
Do you have any of these conditions: bowel obstruction or Intestinal Obstruction or Inflammatory bowel disease or Crohn's Disease or Crohn's Disease (Pediatric) or crohns disease or Intes...?
Do you have any of these conditions: Crohn's Disease (Pediatric) or Intestinal Fistula or Intestinal Diseases or Bowel Dysfunction or Crohn's Disease or bowel obstruction or Short Bowel S...?
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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