Aneurysm, Aortic-cross Clamping Time, Blood Transfusion, Cardiopulmonary Bypass Time, Dialysis, Endoleak, Hospital Stay, Hypothermic Circulatory Arrest Time, ICU Stay, Mechanical Ventilation Time, Morality, Neurological Disorder, Operation Time, Re-Thoracotomy
Conditions
Keywords
Hyperthermic circulatory arrest; Surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREthe temperature of hypothermic circulatory arrest
Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery.
Sponsors
Jie He.MD
Shihao Cai.MD
Wenda Gu.PhD
Haijiang Guo.PhD
Liang Hong. MD
Ruixing Fan.PhD
Jingsong Huang.PhD
Tucheng Sun.MD
Jihai Peng.MD
Xiaoping Fan. MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
A randomised controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1.Patients with confirmed diagnosis (i.e.aortic dissection, marfan syndrome, aortic arch aneurysm and so on), which require total aortic arch replacement.
Exclusion criteria
1. Preoperative heart attack or coma. 2. Patients with surgical contraindication, including but not limited to severe cardiac,pulmonary,renal or hepatic insufficiency. 3. Pre-existing heart condition or neurological disease. 4. Variation of aortic arch or its branch vessels. 5. Patient is currently on anticoagulation therapy or has other medical condition that compromises the coagulation. 6. Patient with active infection. 7. Allergy to anaesthetic or contrast agent. 8. Pregnant or lactating female. 9. Patient is already on other medical trial. 10. Other medical, psychological or socioeconomics condition determined by investigator that is not eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 3 months within surgery. | In-hospital Mortality or other related death |
| Re-thoracotomy | Through the hospitalization, an average of 4 weeks. | Postoperative bleeding or other conditions require re-thoracotomy |
| Neurological disorder | Through the hospitalization, an average of 4 weeks. | Any neurological event occur after surgery, including transient and permanent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | During the operation | the time of the entire surgery. |
| ICU stay | Through the ICU stay, an average of 1 weeks. | the day of ICU treatment |
| Time of mechanical ventilation | Through the use of ventilation, an average of 3 days. | the time of using respirator |
| Blood transfusion | Through the hospitalization, an average of 4 weeks. | the number of blood product during the hospitalization, including red blood cell, platelet, plasma and so on. |
| HCA time | During the operation | the time of hypothermic circulatory arrest |
| Hospital stay | Through the hospitalization, an average of 4 weeks. | the time of hospitalization |
| Postoperative aneurysm | 1 year within the surgery | Aortic aneurysm develope after the surgery |
| Postoperative endoleak | 1 year within the surgery | Stent-graft endoleak occurs after the surgery. |
| Dialysis | Through the hospitalization, an average of 4 weeks. | postoperative renal failure requiring dialysis |
| Aorta-cross clamp time | During the operation | the time of aortic-cross clamp |
| CPB time | During the operation | the time of cardiopulmonary bypass |
Countries
China
Outcome results
None listed