Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03773237
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2018-11-12
Brief Title:
Intralipid Versus SMOFlipid in HPN Patients
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None