San Francisco Veteran Affairs Medical Center
San Francisco, California, 94121, United States
NCT Number: NCT03208920
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.
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Notify Me40 year–90 year
All sexes
Interventional
Not applicable
San Francisco, California, 94121, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.
Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.
Time frame: 6 months
Blunting of the peri-PVI inflammatory response as measured by the area under the curve (AUC) of the inflammatory biomarker high sensitivity C reactive protein (CRP)
Time frame: 6 months
Reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.
University of California, San Francisco
Other
Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.
Acronym: Omega-EVAR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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