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| Name | Class |
|---|---|
| Jie He.MD | UNKNOWN |
| Shihao Cai.MD | UNKNOWN |
| Wenda Gu.PhD | UNKNOWN |
| Haijiang Guo.PhD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hypothermia | Experimental | Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius |
|
| Moderate hypothermia | Active Comparator | Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the temperature of hypothermic circulatory arrest | Procedure | Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | In-hospital Mortality or other related death | 3 months within surgery. |
| Re-thoracotomy | Postoperative bleeding or other conditions require re-thoracotomy | Through the hospitalization, an average of 4 weeks. |
| Neurological disorder | Any neurological event occur after surgery, including transient and permanent. | Through the hospitalization, an average of 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| HCA time | the time of hypothermic circulatory arrest | During the operation |
| Aorta-cross clamp time | the time of aortic-cross clamp | During the operation |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Fan, PhD | Guangdong General Hosiptal | Study Director |
| Jie He, MD | Guangdong General Hosiptal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
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| Liang Hong. MD | UNKNOWN |
| Ruixing Fan.PhD | UNKNOWN |
| Jingsong Huang.PhD | UNKNOWN |
| Tucheng Sun.MD | UNKNOWN |
| Jihai Peng.MD | UNKNOWN |
A randomised controlled study
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| CPB time | the time of cardiopulmonary bypass | During the operation |
| Operation time | the time of the entire surgery. | During the operation |
| ICU stay | the day of ICU treatment | Through the ICU stay, an average of 1 weeks. |
| Time of mechanical ventilation | the time of using respirator | 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. | Through the hospitalization, an average of 4 weeks. |
| Dialysis | postoperative renal failure requiring dialysis | Through the hospitalization, an average of 4 weeks. |
| Hospital stay | the time of hospitalization | Through the hospitalization, an average of 4 weeks. |
| Postoperative aneurysm | Aortic aneurysm develope after the surgery | 1 year within the surgery |
| Postoperative endoleak | Stent-graft endoleak occurs after the surgery. | 1 year within the surgery |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D057867 | Endoleak |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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