Clinical trial NCT01306734: Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods
Official title: Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ascending Aorta Aneurism
Keywords: Extracorporeal circulation
Deep Hypothermic Circulatory Arrest
aortic aneurism
neurological injury
inflammation
coagulation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2011-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary care clinic. Patients eligible for planned ascending aorta aneurism repair under deep hypothermic circulatory arrest.

Brief summary: PURPOSE: To compare crash cooling versus gradient cooling methods for patients undergoing planned surgery on the ascending aorta in deep hypothermic circulatory arrest. To investigate the impact of hypothermia and circulatory arrest on the coagulation, stress-response, and cerebral outcome.

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.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgery on the ascending aorta
* Need for deep hypothermic circulatory arrest during the procedure

Exclusion Criteria:

* Known coagulopathy
* 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

Primary outcomes:
measure: Duration of cooling
timeFrame: intraoperatively
Secondary outcomes:
measure: MRI of cerebrum
timeFrame: Baseline prior to surgery and 4 to 5 days postoperatively
measure: Markers of neurological injury
timeFrame: baseline, postoperative
measure: neurological exam
timeFrame: baseline, postoperative, after 4 months
measure: cognitive test
timeFrame: baseline, postoperative, after 4 months
measure: markers of elevated inflammatory response
timeFrame: perioperatively
measure: Markers of oxidative stress
timeFrame: perioperatively
measure: Coagulation parameters
timeFrame: perioperatively
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of anesthesia and intensive care, Aarhus University Hospital, Skejby
state: Aarhus N
Study officials:
References: