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Completed

NCT Number: NCT03208920

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Veteran Affairs Medical Center

San Francisco, California, 94121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pro-Omega

Dietary Supplement

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

ProOmega Placebo

Other

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

Primary outcomes

  1. Highly Sensitive C-Reactive Protein

    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)

Secondary outcomes

  1. Systemic Inflammatory Markers

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.

Acronym: Omega-EVAR

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2017
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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