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

Not Applicable

• Conditions: Operation Time; ICU Stay; Neurological Disorder; Aneurysm; Re-Thoracotomy; Mechanical Ventilation Time; Morality; Hypothermic Circulatory Arrest Time; Aortic-cross Clamping Time; Cardiopulmonary Bypass Time
• Interventions: Procedure: the temperature of hypothermic circulatory arrest

• Registration Number: NCT03454633
• Lead Sponsor: Xiaoping Fan. MD

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.

Study Timeline

• Study First Submitted: 2018-02-25
• Study First Submitted QC: 2018-03-04
• Study First Posted: 2018-03-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Study Start: 2018-08-03
• Last Update Posted: 2018-08-06
• Primary Completion: 2020-02-15
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mild hypothermia	the temperature of hypothermic circulatory arrest	Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius
Moderate hypothermia	the temperature of hypothermic circulatory arrest	Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius

Primary Outcome Measures

Name	Time	Method
Re-thoracotomy	Through the hospitalization, an average of 4 weeks.	Postoperative bleeding or other conditions require re-thoracotomy
Mortality	3 months within surgery.	In-hospital Mortality or other related death
Neurological disorder	Through the hospitalization, an average of 4 weeks.	Any neurological event occur after surgery, including transient and permanent.

Secondary Outcome Measures

Name	Time	Method
Aorta-cross clamp time	During the operation	the time of aortic-cross clamp
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.
Operation time	During the operation	the time of the entire surgery.
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
CPB time	During the operation	the time of cardiopulmonary bypass
Hospital stay	Through the hospitalization, an average of 4 weeks.	the time of hospitalization
ICU stay	Through the ICU stay, an average of 1 weeks.	the day of ICU treatment
Dialysis	Through the hospitalization, an average of 4 weeks.	postoperative renal failure requiring dialysis

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China