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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-03

Study Completion Date

2020-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Retrograde Versus Antegrade Perfusion in Low-Moderate Hypothermia for Aortic Arch Surgery

NCT06986967

Brain Function Hemiarch Cardiac Procedure

RECRUITING NA

Arterial Stiffness and Hemodynamics in Cardiac Surgery

NCT06911593

Hypotension Anesthesia-Induced Hypotension Arterial Stiffness +1 more

COMPLETED

Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

NCT02834065

Cognition Disorders

COMPLETED NA

Study on the Relationship of Arterial-venous Oxygen Difference and Postoperative Complications After Cardiac Surgery.

NCT05078086

Patient Blood Management Cardiac Surgery Transfusion

COMPLETED

Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

NCT04369443

Cardiac Surgery Acute Normovolemic Hemodilution

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomised controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mild hypothermia

Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius

Group Type EXPERIMENTAL

the temperature of hypothermic circulatory arrest

Intervention Type PROCEDURE

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

Moderate hypothermia

Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius

Group Type ACTIVE_COMPARATOR

the temperature of hypothermic circulatory arrest

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

the temperature of hypothermic circulatory arrest

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No