Intralipid Versus SMOFlipid in HPN Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn Disease
- Intestinal Fistula
- Intestinal Obstruction
- Short Bowel Syndrome
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective Randomized ControlledMasking: 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
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
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.
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.
Tracking Information
- NCT #
- NCT03773237
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Manpreet S Mundi, MD Mayo Clinic