Comparing Mild Versus Moderate Hypothermic Circulatory Arrest With Unilateral Anterograde Cerebral Perfusion in Hemiarch Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Operative mortality
研究概览
简要总结
The aim of our study is to analyze the immediate and long-term results between patients undergoing hemiarch replacement with ACP under mild hypothermic (30-32 °C) circulatory arrest versus moderate hypothermic (26-28 °C) circulatory arrest. It is hypothesized that circulatory arrest using mild hypothermia (30-32°C) and uSACP will result in complications reduction, during aortic hemiarch replacement, when compared to moderate hypothermia (26-28°C) and uSACP. For this purpose all of the patient population will be randomized into 2 groups. The first group of the patients during aortic hemiarch replacement, mild hypothermia (30-32°C) will be used during circulatory arrest. The second group of the patients during aortic hemiarch replacement, moderate hypothermia (26-28°C) will be used during circulatory arrest.
详细描述
Mild versus moderate hypothermic circulatory arrest during aortic hemiarch replacement Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion (SACP) is an important surgical technique, allowing complex aortic surgeries to be performed safely. One of the main positive aspects of the strategy for changing the hypothermia temperature is to reduce the systemic inflammatory response, minimize visceral organ dysfunction, and reduce the risk of postoperative bleeding - the adverse effects of hypothermia Patients will be operated for ascending aortic aneurysm in a hypothermic circulatory arrest with unilateral SACP. The main difference is during aortic hemiarch replacement, moderate hypothermia (26-28°C) and mild hypothermia (30-32°C) will be used during circulatory arrest. All data will be prospectively collected and recorded. All surgeries will be perform concurrently in the same time period. Experienced in aortic pathology surgeons will perform these operations.
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 either 30-32 °C or 26-28 °C, depending on to which treatment arm the patient has been randomized. 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ascending aortic aneurysm
- •Elective aortic hemiarch replacement
- •Able to provide written informed consent
排除标准
- •Surgery for acute aortic dissection or emergent operations
- •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
结局指标
主要结局
Operative mortality
时间窗: During the first 30 days after the procedure
Operative mortality (%) as assessed by data linkage to medical records Comparison of mild (30-32°C) vs moderate (26-28°C) hypothermia in aortic hemiarch surgery with respect to the incidence of death
Composite of neurologic injury
时间窗: During the first 30 days after the procedure
Percentage of patients with neurological complications is assessed. Single assessment by CT or MRI. More often if necessary. Comparison of mild (30-32°C) vs moderate (26-28°C) hypothermia in aortic hemiarch surgery with respect to incidence of neurologic injury, including transient ischemic attack (TIA), permanent neurological dysfunction (PND) or stroke and delirium
Incidence of Acute Kidney Injury (AKI)
时间窗: During the first 30 days after the procedure
The incidence of acute kidney injury (AKI) (%), defined as Stage 1 or greater using the KDIGO criteria. Using the KDIGO criteria, Stage 1 AKI is defined as an increase in serum creatinine of 1.5-1.9x the baseline or an increase \>= 27umol/L with urine output \<0.5 mL/kg/hour for 6-12 hours.
次要结局
- The duration of a patient's stay in the intensive care unit and on the hospital ward(Up to 90 days after surgery)
- Volume of perioperative blood transfusion(During the first 3 days after the procedure)
- Perioperative Myocardial Infarction(During the first 30 days after the procedure (assessed by daily serum assay and ECG in the ICU and every 5 days after discharge from ICU. ))
- Rates of re-exploration for bleeding(During the first 3 days after the procedure)
- Respiratory failure(During the first 30 days after the procedure)
- Duration of cardiopulmonary bypass(During the index procedure)
研究者
Erdeni L. Sonduev
Study Investigator and Coordinator
Tomsk National Research Medical Center of the Russian Academy of Sciences