Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods

Ascending Aorta Aneurism Clinical Trial

Official title:

Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01306734
• Other study ID #: HYPO-SKS-2011
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2011
• Last updated: March 20, 2012
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: University of Aarhus
• Contact: Hans Kirkegaard, MD, Ph.D.
• Phone: +4589498852
• Email: hans.kirkegaard[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Aneurysm
• Ascending Aorta Aneurism
• Hypothermia

Locations

Country	Name	City	State
Denmark	Department of anesthesia and intensive care, Aarhus University Hospital, Skejby	Aarhus	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of cooling		intraoperatively	No
Secondary	MRI of cerebrum	Standard perfusion-weighed Magnetic Resonance imaging of the cerebrum. The same investigator describes all images. No use of contrast agents.	Baseline prior to surgery and 4 to 5 days postoperatively	No
Secondary	Markers of neurological injury	s-100b, Neuron specific enolase	baseline, postoperative	No
Secondary	neurological exam		baseline, postoperative, after 4 months	No
Secondary	cognitive test		baseline, postoperative, after 4 months	No
Secondary	markers of elevated inflammatory response		perioperatively	No
Secondary	Markers of oxidative stress		perioperatively	No
Secondary	Coagulation parameters		perioperatively	No