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临床试验/NCT05839990
NCT05839990已完成不适用

Biomechanical and Elastic Properties of the Ascending Wall of the Human Aorta in Aneurysm

Tomsk National Research Medical Center of the Russian Academy of Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
aortic growth

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
17 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Ascending aortic aneurysm (50 mm and more)
  • •Ascending aortic dilatation (45-49 mm)

排除标准

  • •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

研究组 & 干预措施

Surgery

Active Comparator

Patients with ascending aortic aneurysm and dlatation who undergo surgical tretment

干预措施: Surgery (Procedure)

Non-surgery

No Intervention

Patients with ascending aortic dlatation who undergo surveillance

结局指标

主要结局

aortic growth

时间窗: up to 5 years

assess of the aortic growth in mm during foloow up in nonoperated patients

mortality

时间窗: up to 5 years

assess early and late death cases in aneurysm and dilatation groups in operated and nonoperarted patients

次要结局

未报告次要终点

研究者

研究点 (1)

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