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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

Official Title

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

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 Type

Interventional

Primary Outcome

Highly Sensitive C-Reactive Protein

Secondary Outcome

 Systemic Inflammatory Markers

Condition

PAD

Intervention

Pro-Omega

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Dietary Supplement

Estimated Enrollment

2

Start Date

December 2016

Completion Date

August 28, 2018

Primary Completion Date

March 28, 2018

Eligibility Criteria

        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

Gender

All

Ages

40 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Warren Gasper, M.D, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03208920

Organization ID

15-16505

Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco

Study Sponsor

Warren Gasper, M.D, Principal Investigator, University of California, San Francisco

Verification Date

July 2021