Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods
NCT ID: NCT01306734
Last Updated: 2012-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2011-03-31
2012-12-31
Brief Summary
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BACKGROUND: Cooling to 18 °C using extracorporeal circulation allows for circulatory arrest during surgery on the ascending aorta. Two different methods are used either lowering the temperature of the blood by 10 °C at a time, gradient cooling, or as cold as possible, crash cooling. The distribution of hypothermia is expected to be different for the two methods, the latter predominantly cooling the body core. The influence on the physiological response is expected to vary with the two methods. The surgical procedure and the cooling greatly elicit a stress response and the coagulation is profoundly influenced. There can be adverse effects on the neurological outcome due to the procedure. The two methods are considered equal, but have never been subjected to comparison. The surgery and circulatory changes can have a negative influence on the cerebral outcome .
METHODS: Twenty patients between 18 and 80 yrs randomized either to crash cooling or gradient cooling, ten patients in each group.. Patients with severe comorbidities or known coagulopathy are excluded. Anesthesia and operation as performed routinely in the department. The primary endpoint is duration of cooling, secondary endpoints include coagulation parameters (thromboelastography, clot stability), stress response parameters (adhesion molecule expression on endothelial cells, oxidative stress analysis, inflammatory markers), neuropsychological tests, MRI of the cerebrum, markers of cerebral ischemia, and ultrasound imaging of the great vessels for detection of air bubbles. Baseline values are obtained for all parameters.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Gradient cooling group
Study group receiving gradient cooling during the procedure using extracorporeal circulation (ECC). The procedure is used routinely in the department and is not an experimental procedure. A maximum of 10 degrees celsius is allowed between the measured nasopharyngeal body temperature and the heater-cooler unit of the ECC-machine, when cooling or rewarming.
No interventions assigned to this group
Crash cooling group
Study group receiving rapid cooling using extracorporeal circulation. The protocol for rapid cooling is using routinely in the department and is not an experimental procedure. When cooling, the investigators aim for maximal difference in temperature between the heater-cooler unit of the ECC-machine.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Need for deep hypothermic circulatory arrest during the procedure
Exclusion Criteria
* Ejection fraction less than 30 %
* Severe psychiatric or neurological disease
* Severe liver disease
* Severely reduced lung function
* Glomerular filtration rate less than 15 ml/min/1.73 m2
18 Years
80 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Department of anesthesia and intensive care, Aarhus University Hospital, Skejby
Aarhus, Aarhus N, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HYPO-SKS-2011
Identifier Type: -
Identifier Source: org_study_id
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