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

Abdominal Aortic Aneurysm Clinical Trial

— Omega-EVAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03208920
• Other study ID #: 15-16505
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 28, 2018

Study information

• Verified date: July 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 28, 2018
• Est. primary completion date: March 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Inflammation
• PAD

Intervention

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

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

Locations

Country	Name	City	State
United States	San Francisco Veteran Affairs Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	6 months
Secondary	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.	6 months