Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair
Status: | Recruiting |
---|---|
Conditions: | Cardiology, Cardiology, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 40 - 90 |
Updated: | 1/6/2018 |
Start Date: | December 2016 |
End Date: | November 2019 |
Contact: | Sukaynah A Khetani, B.S |
Email: | sukaynah.khetani@ucsf.edu |
Phone: | 415-353-4368 |
THE OMEGA-EVAR TRIAL: 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.
undergoing EVAR for infra-renal AAA reduces the peri-operative inflammation.
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.
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.
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
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