NCT03454633

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Xiaoping Fan. MD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-03
• Primary completion: 2020-02-15
• Completion: 2020-12-15
• First posted: 2018-03-06
• Last updated: 2018-08-06

Locations

1 site across 1 country: China