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

August 2, 2018 updated by: Xiaoping Fan. MD

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 3 months within surgery.
In-hospital Mortality or other related death
3 months within surgery.
Re-thoracotomy
Time Frame: Through the hospitalization, an average of 4 weeks.
Postoperative bleeding or other conditions require re-thoracotomy
Through the hospitalization, an average of 4 weeks.
Neurological disorder
Time Frame: Through the hospitalization, an average of 4 weeks.
Any neurological event occur after surgery, including transient and permanent.
Through the hospitalization, an average of 4 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HCA time
Time Frame: During the operation
the time of hypothermic circulatory arrest
During the operation
Aorta-cross clamp time
Time Frame: During the operation
the time of aortic-cross clamp
During the operation
CPB time
Time Frame: During the operation
the time of cardiopulmonary bypass
During the operation
Operation time
Time Frame: During the operation
the time of the entire surgery.
During the operation
ICU stay
Time Frame: Through the ICU stay, an average of 1 weeks.
the day of ICU treatment
Through the ICU stay, an average of 1 weeks.
Time of mechanical ventilation
Time Frame: Through the use of ventilation, an average of 3 days.
the time of using respirator
Through the use of ventilation, an average of 3 days.
Blood transfusion
Time Frame: 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.
Through the hospitalization, an average of 4 weeks.
Dialysis
Time Frame: Through the hospitalization, an average of 4 weeks.
postoperative renal failure requiring dialysis
Through the hospitalization, an average of 4 weeks.
Hospital stay
Time Frame: Through the hospitalization, an average of 4 weeks.
the time of hospitalization
Through the hospitalization, an average of 4 weeks.
Postoperative aneurysm
Time Frame: 1 year within the surgery
Aortic aneurysm develope after the surgery
1 year within the surgery
Postoperative endoleak
Time Frame: 1 year within the surgery
Stent-graft endoleak occurs after the surgery.
1 year within the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiaoping Fan. MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Xiaoping Fan, PhD, Guangdong General Hosiptal
  • Principal Investigator: Jie He, MD, Guangdong General Hosiptal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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