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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery.
Guangdong General Hospital
Guangzhou, Guangdong, China
Mortality
In-hospital Mortality or other related death
Time frame: 3 months within surgery.
Re-thoracotomy
Postoperative bleeding or other conditions require re-thoracotomy
Time frame: Through the hospitalization, an average of 4 weeks.
Neurological disorder
Any neurological event occur after surgery, including transient and permanent.
Time frame: Through the hospitalization, an average of 4 weeks.
HCA time
the time of hypothermic circulatory arrest
Time frame: During the operation
Aorta-cross clamp time
the time of aortic-cross clamp
Time frame: During the operation
CPB time
the time of cardiopulmonary bypass
Time frame: During the operation
Operation time
the time of the entire surgery.
Time frame: During the operation
ICU stay
the day of ICU treatment
Time frame: Through the ICU stay, an average of 1 weeks.
Time of mechanical ventilation
the time of using respirator
Time frame: Through the use of ventilation, an average of 3 days.
Blood transfusion
the number of blood product during the hospitalization, including red blood cell, platelet, plasma and so on.
Time frame: Through the hospitalization, an average of 4 weeks.
Dialysis
postoperative renal failure requiring dialysis
Time frame: Through the hospitalization, an average of 4 weeks.
Hospital stay
the time of hospitalization
Time frame: Through the hospitalization, an average of 4 weeks.
Postoperative aneurysm
Aortic aneurysm develope after the surgery
Time frame: 1 year within the surgery
Postoperative endoleak
Stent-graft endoleak occurs after the surgery.
Time frame: 1 year within the surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.