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.

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.

Study Overview

• Status: Unknown
• Conditions: Aneurysm; Blood Transfusion; Dialysis; Neurological Disorder; Morality; Endoleak; Operation Time; Hospital Stay; Hypothermic Circulatory Arrest Time; Aortic-cross Clamping Time; Cardiopulmonary Bypass Time; Re-Thoracotomy; ICU Stay; Mechanical Ventilation Time
• Intervention / Treatment: Procedure: the temperature of hypothermic circulatory arrest

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mild hypothermia; Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius	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.
ACTIVE_COMPARATOR: Moderate hypothermia; Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Xiaoping Fan. MD
• Collaborators: Jie He.MD; Shihao Cai.MD; Wenda Gu.PhD; Haijiang Guo.PhD; Liang Hong. MD; Ruixing Fan.PhD; Jingsong Huang.PhD; Tucheng Sun.MD; Jihai Peng.MD
• Investigators: Study Director: Xiaoping Fan, PhD, Guangdong General Hosiptal; Principal Investigator: Jie He, MD, Guangdong General Hosiptal

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2018
• Primary Completion (ANTICIPATED): February 15, 2020
• Study Completion (ANTICIPATED): December 15, 2020

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: March 4, 2018
• First Posted (ACTUAL): March 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Hyperthermic circulatory arrest; Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hemorrhage; Body Temperature Changes; Postoperative Hemorrhage; Nervous System Diseases; Heart Arrest; Aneurysm; Hypothermia; Endoleak
• Other Study ID Numbers: 2017316H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No