Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
The purpose of this study is to compare brain function after surgical circulatory arrest using either antegrade perfusion or retrograde perfusion.
详细描述
The purpose of this study is to compare brain function after surgical circulatory arrest (surgeon stops the heart-lung machine to work on the heart) in antegrade perfusion versus retrograde perfusion. There are 2 ways to supply blood to the brain, antegrade and retrograde perfusion. In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain. In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.
It is standard practice to cool the patient down during this type of surgery to help protect the brain. Despite measures to safeguard brain health, some patients still experience postoperative cognitive decline such as confusion, delirium and agitation. The investigators are conducting this study to see which method of perfusing the brain is superior and decreases the symptoms of confusion, delirium and agitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The neuroimaging personnel will be blinded to the assignment of the subject.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •Participant's that are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi-arch replacement via median sternotomy
排除标准
- •< 18 years of age
- •history of symptomatic cerebrovascular disease, e.g., prior stroke with residual deficit
- •current alcoholism (> 2 drinks/day)
- •current psychiatric illness requiring pharmacotherapy
- •current drug abuse (any illicit drug use in the past 3 months)
- •hepatic insufficiency (liver function tests > 1.5 times the upper limit of normal)
- •severe pulmonary insufficiency (requiring home oxygen therapy)
- •renal failure (serum creatinine > 2.0 mg/dL)
- •claustrophobic fear
- •unable to read and thus unable to complete the cognitive testing
- •pregnant women
- •patients who score <19 om the Montreal Cognitive Assessment (MoCA) or ≥27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale
- •patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI)
- •Patients who have received chemotherapy in the last 12 months or radiation to the brain
研究组 & 干预措施
Arm 1: Antegrade Perfusion
In antegrade perfusion, the surgeon accesses one of two arteries that branch off from the aorta (the artery that delivers blood to the rest of the body) to provide blood to the brain.
干预措施: Antegrade Perfusion (Procedure)
Arm 2: Retrograde Perfusion
In retrograde perfusion, the surgeon accesses the superior vena cava (large vein bringing blood back to the heart) to supply blood to the brain.
干预措施: Retrograde Perfusion (Procedure)
结局指标
主要结局
Change in neurocognitive function as measured by the Montreal Cognitive Assessment (MoCA)
时间窗: Baseline to 4 weeks
The MoCA is a brief screening tool used to assess cognitive function. It consists of 30 tasks covering various cognitive domains, including attention, memory, visuospatial abilities, and executive function. The total score ranges from 0 to 30, where a higher score indicates better cognitive function.
次要结局
- Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on brain white matter patency(Baseline, prior to discharge from hospital (up to 7 days), and at 4 weeks)
- Effect of Antegrade Perfusion (ACP) vs Retrograde Perfusion (RCP) on functional connectivity(Baseline and at 4 weeks)