Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair

N/ACompletedNCT03208920

University of California, San Francisco2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

PAD Abdominal Aortic Aneurysm

Interventions

Pro-OmegaDIETARY_SUPPLEMENT

Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.

ProOmega PlaceboOTHER

Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

San Francisco Veteran Affairs Medical Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Highly Sensitive C-Reactive Protein

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

Secondary Outcomes

Systemic Inflammatory Markers

Reduce circulating pro-inflammatory markers (PIMs) and increase pro-resolution mediators (PRMs) assayed using targeted metabolo-lipidomics, increase PRM production within peripheral circulating monocytes.

Time frame: 6 months

Data from ClinicalTrials.gov

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