A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.

Dialysis Clinical Trial

Official title:

A Comparative Study of Mild Hypothermic Circulatory Arrest Versus Moderate Hypothermic Circulatory Arrest on Aortic Surgery.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03454633
• Other study ID #: 2017316H
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: August 2018
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic-cross Clamping Time
• Blood Transfusion
• Cardiopulmonary Bypass Time
• Dialysis
• Endoleak
• Heart Arrest
• Hospital Stay
• Hypothermia
• Hypothermic Circulatory Arrest Time
• ICU Stay
• Mechanical Ventilation Time
• Morality
• Nervous System Diseases
• Neurological Disorder
• Operation Time
• Re-Thoracotomy

Intervention

Procedure:
• the temperature of hypothermic circulatory arrest
Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (10)

Lead Sponsor	Collaborator
Xiaoping Fan. MD	Haijiang Guo.PhD, Jie He.MD, Jihai Peng.MD, Jingsong Huang.PhD, Liang Hong. MD, Ruixing Fan.PhD, Shihao Cai.MD, Tucheng Sun.MD, Wenda Gu.PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	In-hospital Mortality or other related death	3 months within surgery.
Primary	Re-thoracotomy	Postoperative bleeding or other conditions require re-thoracotomy	Through the hospitalization, an average of 4 weeks.
Primary	Neurological disorder	Any neurological event occur after surgery, including transient and permanent.	Through the hospitalization, an average of 4 weeks.
Secondary	HCA time	the time of hypothermic circulatory arrest	During the operation
Secondary	Aorta-cross clamp time	the time of aortic-cross clamp	During the operation
Secondary	CPB time	the time of cardiopulmonary bypass	During the operation
Secondary	Operation time	the time of the entire surgery.	During the operation
Secondary	ICU stay	the day of ICU treatment	Through the ICU stay, an average of 1 weeks.
Secondary	Time of mechanical ventilation	the time of using respirator	Through the use of ventilation, an average of 3 days.
Secondary	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.
Secondary	Dialysis	postoperative renal failure requiring dialysis	Through the hospitalization, an average of 4 weeks.
Secondary	Hospital stay	the time of hospitalization	Through the hospitalization, an average of 4 weeks.
Secondary	Postoperative aneurysm	Aortic aneurysm develope after the surgery	1 year within the surgery
Secondary	Postoperative endoleak	Stent-graft endoleak occurs after the surgery.	1 year within the surgery