Biomechanical and Elastic Properties of the Ascending Wall of the Human Aorta in Aneurysm
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- aortic growth
Study Overview
Brief Summary
The aim of the study is to analyze the efficacy of the surgical tretment in patients with ascending aortic aneurysm and dilatation. And to assess rate of negative clinical scenarios in non-oparated patients with ascending aortic dilatation
Detailed Description
Description of the procedures:
All surgical procedures will be performed via median sternotomy. During the aortic arch anastomosis, continuous, unilateral SACP using innominate artery will be employed. Unilateral SACP may be converted to bilateral ACP at the surgeon's discretion if adequate cerebral flows are not achieved or if there are concerns with cerebral oximetry measurements.
Once on CPB, the patient will be cooled to a nasopharyngeal (NP) temperature of 28-30 °C. Rectal temperature with be monitored as an additional temperature sites. Unilateral SACP will only be initiated once the target temperature has been reached. SACP via the innominate artery will be commenced with target flows of 8-10 ml/kg/min and perfusion pressure of 60-80 mmHg. Perfusion adequacy will be evaluated using measurement of blood pressure in both radial arteries and cerebral oximetry using near-infrared spectroscopy (NIRS).
After completion of the aortic hemiarch replacement, CPB will be resumed and the patient re-warmed to 36 °C prior to coming off CPB, with a = 1 °C temperature difference between temperature monitoring sites (NP and rectal).
Intraoperative information will be collected from the anesthetic record, surgical notes and perfusion records. Intraoperative data collection will include total operative time, CPB time, cross-clamp time, hypothermic cardiac arrest time, uSACP time, lowest nasopharyngeal and rectal temperature, arterial pressure in both radial arteries, perfusion rate and perfusion pressure during both of CPB and unilateral SACP, lowest hemoglobin concentration (g/L) and hematocrit (%), acid-base indices, intraoperative red blood cell transfusion (units), highest dose/agent used for intraoperative inotrope or vasopressor support. Also during the surgery will be performed NIRS and BIS-monitoring.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 17 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ascending aortic aneurysm (50 mm and more)
- •Ascending aortic dilatation (45-49 mm)
Exclusion Criteria
- •Aortic dissection
- •Patients with known/documented coagulopathy
- •Oncological disease (high degrees)
- •Severe chronic heart failure
- •Refusal of surgical treatment
- •Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- •Severe carotid disease, defined as: any patient with previously documented carotid stenosis of > 70%, without neurological deficits; or carotid stenosis > 50% with neurological deficits; or previous carotid endarterectomy or stenting
- •Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon
Arms & Interventions
Surgery
Patients with ascending aortic aneurysm and dlatation who undergo surgical tretment
Intervention: Surgery (Procedure)
Non-surgery
Patients with ascending aortic dlatation who undergo surveillance
Outcomes
Primary Outcomes
aortic growth
Time Frame: up to 5 years
assess of the aortic growth in mm during foloow up in nonoperated patients
mortality
Time Frame: up to 5 years
assess early and late death cases in aneurysm and dilatation groups in operated and nonoperarted patients
Secondary Outcomes
No secondary outcomes reported