A Comparative Study of Mild Hypothermic Circulatory Arrest Versus Moderate Hypothermic Circulatory Arrest on Aortic Surgery.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Re-thoracotomy
研究概览
简要总结
By comparing the clinical outcome of patients underwent different hypothermic circulatory arrest (mild hypothermic versus moderate hypothermic) during aortic arch surgery, this study aims to determine the optimal hypothermic circulatory arrest strategy for aortic surgery.
详细描述
Hypothermic circulatory arrest (HCA) is the cornerstone of aortic surgery. It provides a bloodless and still operative field. But the side effect of hypothermia also draws people's concern. With the development of surgical techniques and cardiopulmonary bypass (CPB) management, the temperature of HCA has been raised from deep hypothermia (14.1-20 degree) to moderate hypothermia (20.1-28 degree), and it has been a primary choice for many surgeons around the world. Some of surgeons still tried to push the limit and started using mild hypothermia (28.1-34 degree), and satisfactory outcome was obtained. However, the optimal temperature of HCA has not yet been determined.
In this randomized controlled study, 80 informed and consenting patients who are scheduled for total arch replacement with concomitant proximal aortic reconstruction will be randomized to mild (28.1-34 degree) or moderate (20.1-28 degree) hypothermia during circulatory arrest. Clinical outcomes of both groups will be analyzed to determine the optimal temperature for HCA.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients with confirmed diagnosis (i.e.aortic dissection, marfan syndrome, aortic arch aneurysm and so on), which require total aortic arch replacement.
排除标准
- •Preoperative heart attack or coma.
- •Patients with surgical contraindication, including but not limited to severe cardiac,pulmonary,renal or hepatic insufficiency.
- •Pre-existing heart condition or neurological disease.
- •Variation of aortic arch or its branch vessels.
- •Patient is currently on anticoagulation therapy or has other medical condition that compromises the coagulation.
- •Patient with active infection.
- •Allergy to anaesthetic or contrast agent.
- •Pregnant or lactating female.
- •Patient is already on other medical trial.
- •Other medical, psychological or socioeconomics condition determined by investigator that is not eligible for the study.
研究组 & 干预措施
Mild hypothermia
Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius
干预措施: the temperature of hypothermic circulatory arrest (Procedure)
Moderate hypothermia
Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius
干预措施: the temperature of hypothermic circulatory arrest (Procedure)
结局指标
主要结局
Re-thoracotomy
时间窗: Through the hospitalization, an average of 4 weeks.
Postoperative bleeding or other conditions require re-thoracotomy
Mortality
时间窗: 3 months within surgery.
In-hospital Mortality or other related death
Neurological disorder
时间窗: Through the hospitalization, an average of 4 weeks.
Any neurological event occur after surgery, including transient and permanent.
次要结局
- HCA time(During the operation)
- Aorta-cross clamp time(During the operation)
- Postoperative aneurysm(1 year within the surgery)
- Postoperative endoleak(1 year within the surgery)
- Operation time(During the operation)
- Time of mechanical ventilation(Through the use of ventilation, an average of 3 days.)
- Blood transfusion(Through the hospitalization, an average of 4 weeks.)
- CPB time(During the operation)
- Hospital stay(Through the hospitalization, an average of 4 weeks.)
- ICU stay(Through the ICU stay, an average of 1 weeks.)
- Dialysis(Through the hospitalization, an average of 4 weeks.)
研究者
Xiaoping Fan. MD
Chief Physician
Guangdong Provincial People's Hospital