A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 282
- 试验地点
- 20
- 主要终点
- Composite endpoint of neurologic and acute kidney injury
研究概览
简要总结
Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic surgeries to be performed safely. Hypothermic circulatory arrest provides protection to cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these consequences, a trend towards warmer core body temperatures during circulatory arrest has emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C) hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the length of cardiopulmonary bypass time and other key measures of morbidity and mortality.
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
- Double (Participant, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Elective aortic hemiarch surgery
- •Planned unilateral selective anterograde cardioplegia
- •Anticipated lower body arrest time of < 20 minutes
- •Able to provide written informed consent
排除标准
- •Surgery for acute aortic dissection or emergent operations
- •Total arch replacement
- •Inability to perform unilateral selective anterograde cerebral perfusion (uSACP)
- •Patients with known/documented coagulopathy
- •Patients with cold agglutinin disease or those that test positive on routine preop screening
- •Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon
- •Severe carotid disease, defined as: any patient with previously documented carotid stenosis of > 70% (via Doppler ultrasound (US), magnetic resonance angiography (MRA), or computer tomography angiography (CTA)) without neurological deficits; or carotid stenosis > 50% with neurological deficits; or previous carotid endarterectomy or stenting
- •Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- •Use of an investigational drug or device at time of enrollment
- •Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes
研究组 & 干预措施
Mild Hypothermic Circulatory Arrest
During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest.
干预措施: Hypothermic circulatory arrest (Procedure)
Moderate Hypothermic Circulatory Arrest
During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest.
干预措施: Hypothermic circulatory arrest (Procedure)
结局指标
主要结局
Composite endpoint of neurologic and acute kidney injury
时间窗: Up to 90 days after surgery.
The primary objective of this study is to determine whether mild hypothermia (32°C) during aortic hemiarch surgery using unilateral selective anterograde cerebral perfusion (uSACP), is superior to moderate hypothermia (26°C) in reducing the composite endpoint of neurologic and acute kidney injury.
次要结局
- Quality of life (SF-12)(Up to 90 days after surgery.)
- Perioperative Myocardial Infarction(Up to 48 hours after surgery.)
- Rates of Mediastinal re-exploration for bleeding(Up to 90 days after surgery.)
- Length of Stay(Up to 90 days after surgery.)
- Rates of Neurologic Injury(Up to 90 days after surgery.)
- Death(Up to 90 days after surgery.)
- Incidence of Silent Strokes(Up to 90 days after surgery.)
- Incidence of Acute Kidney Injury (AKI)(Up to 90 days after surgery.)
- Incidence of Delirium(Up to 90 days after surgery.)
- Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery(During the index procedure)
- Incidence of prolonged Mechanical Ventilation(Up to 90 days after surgery.)
- Incidence and quantity of perioperative blood transfusions(Up to 90 days after surgery.)