NCT03773237

Intralipid Versus SMOFlipid in HPN Patients

Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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/indirect 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.

Conditions

• Short Bowel Syndrome
• Intestinal Fistula
• Crohn Disease
• Intestinal Obstruction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-12-31
• Primary completion: 2023-12-01
• Completion: 2024-10-01
• First posted: 2018-12-12
• Last updated: 2025-05-16

Locations

1 site across 1 country: United States