An interventional study of the temperature of hypothermic circulatory arrest in Morality, Hypothermic Circulatory Arrest Time and Aortic-cross Clamping Time, sponsored by Xiaoping Fan. MD. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-06.
Sponsored by Xiaoping Fan. MD · Not applicable, Interventional, and Treatment
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.
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.
757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.
This study's planned enrollment of 80 is above the median of 55 across 495 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →This is the only study on the registry with Xiaoping Fan. MD as lead sponsor.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius
Procedure: the temperature of hypothermic circulatory arrest
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.
Mortality
In-hospital Mortality or other related death
Time frame: 3 months within surgery.
Re-thoracotomy
Postoperative bleeding or other conditions require re-thoracotomy
Time frame: Through the hospitalization, an average of 4 weeks.
Neurological disorder
Any neurological event occur after surgery, including transient and permanent.
Time frame: Through the hospitalization, an average of 4 weeks.
HCA time
the time of hypothermic circulatory arrest
Time frame: During the operation
Aorta-cross clamp time
the time of aortic-cross clamp
Time frame: During the operation
CPB time
the time of cardiopulmonary bypass
Time frame: During the operation
Operation time
the time of the entire surgery.
Time frame: During the operation
ICU stay
the day of ICU treatment
Time frame: Through the ICU stay, an average of 1 weeks.
Time of mechanical ventilation
the time of using respirator
Time frame: 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.
Time frame: Through the hospitalization, an average of 4 weeks.
Dialysis
postoperative renal failure requiring dialysis
Time frame: Through the hospitalization, an average of 4 weeks.
Hospital stay
the time of hospitalization
Time frame: Through the hospitalization, an average of 4 weeks.
Postoperative aneurysm
Aortic aneurysm develope after the surgery
Time frame: 1 year within the surgery
Postoperative endoleak
Stent-graft endoleak occurs after the surgery.
Time frame: 1 year within the surgery
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2018 (actual). Primary completion is estimated for Feb 2020, 18 months after the start.
Of 167 non-industry interventional studies with no phase under Nervous System Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 18 months is below that.
Counting every sponsor, half of 193 studies reached it within 30 months; a quarter within 11 and three quarters within 57.
Nervous System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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