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

Not Applicable

Completed

• Conditions: PAD; Abdominal Aortic Aneurysm
• Interventions: Other: ProOmega Placebo; Dietary Supplement: Pro-Omega

• Registration Number: NCT03208920
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Primary Completion: 2018-03-28
• Study Completion: 2018-08-28
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-13
• Last Update Posted: 2021-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Undergoing EVAR for infra-renal AAA and/or iliac artery aneurysm

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	ProOmega Placebo	Pro-Omega Placebo soybean capsules (Nordic Naturals, Watsonville, CA, USA); 4400mg/day x 6 months
Pro-Omega	Pro-Omega	High-dose, short-duration dietary omega-3 fatty acids supplementation; 4400 mg/day x 6 months (Nordic Naturals, Watsonville, CA, USA)

Primary Outcome Measures

Name	Time	Method
Highly Sensitive C-Reactive Protein	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)

Secondary Outcome Measures

Name	Time	Method
Systemic Inflammatory Markers	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.

Trial Locations

Locations (1)

San Francisco Veteran Affairs Medical Center; 🇺🇸 San Francisco, California, United States