Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03208920
Status:
COMPLETED
Last Update Posted:
2021-07-14
First Post:
2017-07-03
Brief Title:
Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Omega EVAR Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair
Status:
COMPLETED
Status Verified Date:
2021-07
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:
Omega-EVAR
Brief Summary:
The purpose of this study is to determine if high-dose PUFA supplementation in patients undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation
Detailed Description:
In this 21 double-blind randomized placebo controlled trial subjects will be given an active drug of n-3 polyunsaturated fatty acids PUFAs or a placebo soybean oil for about two weeks prior to an endovascular abdominal aortic repair EVAR and subsequently six months after the procedure
An EVAR is known to produce a systemic inflammatory response with an increased risk of prolonged hospitalization and complicated post-operative recovery with cardiac events renal and pulmonary dysfunction and multiple organ failure The study proposed here has the potential to provide valuable insight on the role of nutritional intervention to improve outcomes related to surgical revascularization
An EVAR is known to produce a systemic inflammatory response with an increased risk of prolonged hospitalization and complicated post-operative recovery with cardiac events renal and pulmonary dysfunction and multiple organ failure The study proposed here has the potential to provide valuable insight on the role of nutritional intervention to improve outcomes related to surgical revascularization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None