Brief Title
Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair
Official Title
Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.
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 2:1 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.
Study Type
Interventional
Primary Outcome
Highly Sensitive C-Reactive Protein
Secondary Outcome
Systemic Inflammatory Markers
Condition
PAD
Intervention
Pro-Omega
Study Arms / Comparison Groups
Pro-Omega
Description: High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
2
Start Date
December 2016
Completion Date
August 28, 2018
Primary Completion Date
March 28, 2018
Eligibility Criteria
Inclusion Criteria: - Undergoing EVAR for infra-renal AAA and/or iliac artery aneurysm Exclusion Criteria: - Age < 40 or > 90 years - On dual antiplatelet therapy or anticoagulation - Evidence of active infection - Diagnosed hypercoagulable state - Non-atherosclerotic/aneurysmal disease as indication for procedure - Chronic liver disease or myopathy - End-stage renal disease (CKD 5) - Poorly controlled diabetes (HbA1C > 8%) - Recent other major surgery or illness within 6 weeks - Use of immunosuppressive medication or extant chronic inflammatory disorders - History of organ transplantation - Pregnancy or plans to become pregnant - Condition in which patient life expectancy is less than one year - Known allergy to fish or fish products - Presence of symptomatic or ruptured AAA
Gender
All
Ages
40 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Warren Gasper, M.D, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03208920
Organization ID
15-16505
Responsible Party
Sponsor
Study Sponsor
University of California, San Francisco
Study Sponsor
Warren Gasper, M.D, Principal Investigator, University of California, San Francisco
Verification Date
July 2021