MoralityNCT03454633
A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.
A study testing the temperature of hypothermic circulatory arrest in people with Morality and Hypothermic Circulatory Arrest Time, run by Xiaoping Fan. MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morality, Hypothermic Circulatory Arrest Time, Aortic-cross Clamping Time
- What is being tested?
- the temperature of hypothermic circulatory arrest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2018to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Patients with confirmed diagnosis (i.e.aortic dissection, marfan syndrome, aortic arch aneurysm and so on), which require total aortic arch replacement.
Who cannot join
- Preoperative heart attack or coma.
- Patients with surgical contraindication, including but not limited to severe cardiac,pulmonary,renal or hepatic insufficiency.
- Pre-existing heart condition or neurological disease.
- Variation of aortic arch or its branch vessels.
- Patient is currently on anticoagulation therapy or has other medical condition that compromises the coagulation.
- Patient with active infection.
Show all 10Show fewer
- Allergy to anaesthetic or contrast agent.
- Pregnant or lactating female.
- Patient is already on other medical trial.
- Other medical, psychological or socioeconomics condition determined by investigator that is not eligible for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- the temperature of hypothermic circulatory arrest
- Keywords
- Hyperthermic circulatory arrest; Surgery
- Medical subject headings
- Nervous System Diseases, Aneurysm, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the temperature of hypothermic circulatory arrestProcedure or surgery
Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Mild hypothermia | Experimental | Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius Receives: Procedure: the temperature of hypothermic circulatory arrest |
| Moderate hypothermia | Active comparator | Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius Receives: Procedure: the temperature of hypothermic circulatory arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital Mortality or other related death
Measured: 3 months within surgery.
Re-thoracotomy
Postoperative bleeding or other conditions require re-thoracotomy
Measured: Through the hospitalization, an average of 4 weeks.
Neurological disorder
Any neurological event occur after surgery, including transient and permanent.
Measured: Through the hospitalization, an average of 4 weeks.
Secondary outcomes (11)
HCA time
the time of hypothermic circulatory arrest
Measured: During the operation
Aorta-cross clamp time
the time of aortic-cross clamp
Measured: During the operation
CPB time
the time of cardiopulmonary bypass
Measured: During the operation
Operation time
the time of the entire surgery.
Measured: During the operation
ICU stay
the day of ICU treatment
Measured: Through the ICU stay, an average of 1 weeks.
Time of mechanical ventilation
the time of using respirator
Measured: 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.
Measured: Through the hospitalization, an average of 4 weeks.
Dialysis
postoperative renal failure requiring dialysis
Measured: Through the hospitalization, an average of 4 weeks.
Hospital stay
the time of hospitalization
Measured: Through the hospitalization, an average of 4 weeks.
Postoperative aneurysm
Aortic aneurysm develope after the surgery
Measured: 1 year within the surgery
Postoperative endoleak
Stent-graft endoleak occurs after the surgery.
Measured: 1 year within the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start3 Aug 2018
- Primary completion15 Feb 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoping Fan. MD
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Xiaoping Fan. MD, Guangdong Provincial People's Hospital
- Investigators
- Xiaoping Fan, PhD, Study director, Guangdong General HosiptalJie He, MD, Principal investigator, Guangdong General Hosiptal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454633
- Sponsor's protocol ID
- 2017316H
- Status last verified
- Aug 2018
- First submitted
- 25 Feb 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Mild Hypothermic Circulatory Arrest Versus Moderate Hypothermic Circulatory Arrest on Aortic Surgery.
- ClinicalTrials.gov ID
- NCT03454633
- Acronym / sponsor ID
- 2017316H
- Conditions
- Morality, Hypothermic Circulatory Arrest Time, Aortic-cross Clamping Time, Cardiopulmonary Bypass Time, Operation Time, Re-Thoracotomy
- Keywords
- Hyperthermic circulatory arrest; Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xiaoping Fan. MDUniversity, hospital or other
- 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
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 6 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomised controlled study
| Arm | Type | Receives |
|---|---|---|
| Mild hypothermia | Experimental | Procedure: the temperature of hypothermic circulatory arrestInitiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius |
| Moderate hypothermia | Active comparator | Procedure: the temperature of hypothermic circulatory arrestInitiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Patients with confirmed diagnosis (i.e.aortic dissection, marfan syndrome, aortic arch aneurysm and so on), which require total aortic arch replacement.
Key exclusion criteria (10 listed)
- Preoperative heart attack or coma.
- Patients with surgical contraindication, including but not limited to severe cardiac,pulmonary,renal or hepatic insufficiency.
- Pre-existing heart condition or neurological disease.
- Variation of aortic arch or its branch vessels.
- Patient is currently on anticoagulation therapy or has other medical condition that compromises the coagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the temperature of hypothermic circulatory arrestDifferent temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery. | Procedure or surgery | Mild hypothermia, Moderate hypothermia |
Primary outcome
Mortality
Time frame: 3 months within surgery.
In-hospital Mortality or other related death
Re-thoracotomy
Time frame: Through the hospitalization, an average of 4 weeks.
Postoperative bleeding or other conditions require re-thoracotomy
Neurological disorder
Time frame: Through the hospitalization, an average of 4 weeks.
Any neurological event occur after surgery, including transient and permanent.
11 secondary outcomes
HCA time
Time frame: During the operation
Aorta-cross clamp time
Time frame: During the operation
CPB time
Time frame: During the operation
Operation time
Time frame: During the operation
ICU stay
Time frame: 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.
Blood transfusion
Time frame: Through the hospitalization, an average of 4 weeks.
Dialysis
Time frame: Through the hospitalization, an average of 4 weeks.
Hospital stay
Time frame: Through the hospitalization, an average of 4 weeks.
Postoperative aneurysm
Time frame: 1 year within the surgery
Postoperative endoleak
Time frame: 1 year within the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoping Fan, PhD study director
Guangdong General Hosiptal
Jie He, MD principal investigator
Guangdong General Hosiptal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the temperature of hypothermic circulatory arrest in people with Morality and Hypothermic Circulatory Arrest Time, run by Xiaoping Fan. MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 3 months within surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.