Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair (Omega-EVAR)

University of California San Francisco (UCSF)

Status: Completed

Conditions: PAD; Abdominal Aortic Aneurysm

Treatments: Other: ProOmega Placebo; Dietary Supplement: Pro-Omega

Study type: Interventional

Funder types: Other

Identifiers

NCT03208920

15-16505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

Pro-Omega

Experimental group

Description:

High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA)

Treatment:

Dietary Supplement: Pro-Omega

Placebo

Placebo Comparator group

Description:

Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4400mg/day x 6 months

Treatment:

Other: ProOmega Placebo