Omega EVAR: Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Highly Sensitive C-Reactive Protein
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing EVAR for infra-renal AAA and/or iliac artery aneurysm
排除标准
- •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
结局指标
主要结局
Highly Sensitive C-Reactive Protein
时间窗: 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)
次要结局
- Systemic Inflammatory Markers(6 months)