Clinical trial NCT03208920: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PAD
Abdominal Aortic Aneurysm
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 2
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Highly Sensitive C-Reactive Protein
timeFrame: 6 months
Secondary outcomes:
measure: Systemic Inflammatory Markers
timeFrame: 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veteran Affairs Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Warren Gasper, M.D
role: PRINCIPAL_INVESTIGATOR
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