Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair
Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.
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.
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.
Highly Sensitive C-Reactive Protein
Systemic Inflammatory Markers
Study Arms / Comparison Groups
Description: High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA)
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
August 28, 2018
Primary Completion Date
March 28, 2018
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
40 Years - 90 Years
Accepts Healthy Volunteers
Warren Gasper, M.D, ,
University of California, San Francisco
Warren Gasper, M.D, Principal Investigator, University of California, San Francisco