Clinical trial NCT03454633: A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.
Official title: A Comparative Study of Mild Hypothermic Circulatory Arrest Versus Moderate Hypothermic Circulatory Arrest on Aortic Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Keywords: Hyperthermic circulatory arrest; Surgery
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Jie He.MD
name: Shihao Cai.MD
name: Wenda Gu.PhD
name: Haijiang Guo.PhD
name: Liang Hong. MD
name: Ruixing Fan.PhD
name: Jingsong Huang.PhD
name: Tucheng Sun.MD
name: Jihai Peng.MD
First posted: 2018-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised controlled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: 3 months within surgery.
measure: Re-thoracotomy
timeFrame: Through the hospitalization, an average of 4 weeks.
measure: Neurological disorder
timeFrame: Through the hospitalization, an average of 4 weeks.
Secondary outcomes:
measure: HCA time
timeFrame: During the operation
measure: Aorta-cross clamp time
timeFrame: During the operation
measure: CPB time
timeFrame: During the operation
measure: Operation time
timeFrame: During the operation
measure: ICU stay
timeFrame: Through the ICU stay, an average of 1 weeks.
measure: Time of mechanical ventilation
timeFrame: Through the use of ventilation, an average of 3 days.
measure: Blood transfusion
timeFrame: Through the hospitalization, an average of 4 weeks.
measure: Dialysis
timeFrame: Through the hospitalization, an average of 4 weeks.
measure: Hospital stay
timeFrame: Through the hospitalization, an average of 4 weeks.
measure: Postoperative aneurysm
timeFrame: 1 year within the surgery
measure: Postoperative endoleak
timeFrame: 1 year within the surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong General Hosiptal
name: Xiaoping Fan, PhD
role: STUDY_DIRECTOR
affiliation: Guangdong General Hosiptal
name: Jie He, MD
role: PRINCIPAL_INVESTIGATOR
References: