A Study to Compare Intralipid Versus SMOFlipid in New Home Parenteral Nutrition (HPN) Patients

Overview

Información sobre este estudio

The primary aim of the study will be to assess impact on direct bilirubin with the use of Intralipid versus Smoflipid.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Subjects between ages of 18-75 years old.
  • 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 < 18 years.
  • Pregnant and lactating women.
  • Failure to provide consent.
  • Patients with underlying liver dysfunction (defined as liver function studies ≥ 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 > 1,000 mg/dL.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Manpreet Mundi, M.D.

Cerrado para la inscripción

Contact information:

Osman Mohamed Elfadil M.B.B.S.

(507) 284-4080

MohamedElfadil.Osman@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20417137

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