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

NCT01306734 | Unknown

• 1 other identifier: HYPO-SKS-2011
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ascending Aorta Aneurism

Keywords

Extracorporeal circulation; Deep Hypothermic Circulatory Arrest; aortic aneurism; neurological injury; inflammation; coagulation

Outcome Measures

Primary Outcomes (1)

• Duration of cooling

  intraoperatively

Secondary Outcomes (7)

• MRI of cerebrum

  Baseline prior to surgery and 4 to 5 days postoperatively

• Markers of neurological injury

  baseline, postoperative

• neurological exam

  baseline, postoperative, after 4 months

• cognitive test

  baseline, postoperative, after 4 months

• markers of elevated inflammatory response

  perioperatively

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Tertiary care clinic. Patients eligible for planned ascending aorta aneurism repair under deep hypothermic circulatory arrest.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of anesthesia and intensive care, Aarhus University Hospital, Skejby

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bloodsamples serum plasma

MeSH Terms

Conditions

Trauma, Nervous System; Inflammation; Thrombosis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hans Kirkegaard, MD, Ph.D.

CONTACT

+4589498852; hans.kirkegaard@dadlnet.dk

Kristian K Andersen, MD

CONTACT

+4521680494; kristian.kjaer.andersen@ki.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: March 2, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

DK (1)