"The Effect of Stellate Ganglion Block on Brain Haemodynamics and the Inflammatory Response in Moderate and Severe Brain Injury"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in diameter of the cerebral arteries
研究概览
简要总结
Blood flow through the brain is reduced after brain damage. Secondary brain ischemia caused by hypoxia and hypotension, further increase the susceptibility of the ischemically compromised brain to secondary impairment during this period. In order to determine whether and to what extent blockage of the stellate ganglion (BSG) affects the blood flow to the injured brain, the investigators will measure the variables of brain blood flow before and after BSG using computed tomography angiography (CTA), trans-cranial Doppler ultrasound (TCD), intracranial pressure (ICP) and perfusion computed tomography (PCT) of the brain. At the same time, the investigators would like to evaluate whether and to what extent BSG affects the aseptic inflammatory brain injury response and the biochemical indicators of brain damage in patients with moderate and severe brain injury.
详细描述
Hypothesis
Stellate ganglion blockade in patients with moderate and severe brain damage:
- Increases the diameter of the brain arteries and blood flow through the brain
- Do not interfere with intracranial pressure
- Reduces aseptic inflammatory reaction of the damaged brains measured by IL-6 and reduces damage of the brain tissue measured by protein S100B (S100B), neuron specific enolase (NSE) and glial fibrillary acidic protein (GFAP).
Study design and method description
The study will include 40 subjects of both sexes (18-70 years old) with moderate and severe head injury who will be treated surgically and/or conservatively at the Intensive Care Center (CIT) of the Department of Anesthesiology and Intensive Care UKC Ljubljana. The study will include patients who underwent computed tomography angiography of the brain (CTA) and received an intra-parenchymal intracranial pressure monitor electrode (ICP) at admission to the UKC Ljubljana Emergency Center or during CIT treatment. After primary conservative or surgical care, the subjects will be transferred for further treatment at CIT. Subjects will be sedated and mechanically ventilated. To maintain target cerabral perfusion pressure (CPP), the investigators will give an infusion of noradrenaline as needed. The study will not include subjects with primary decompression craniectomy and radiological signs of progression of intracranial hematomas, subjects in a barbiturate coma, and subjects with a norepinephrine dose greater than 0.2 mcg/kg/min. The study will not include pregnant women, children, patients with known hypersensitivity to iodine contrast media and local anesthetics, and patients with poor renal function (estimated glomerular filtration below 30ml / min / 1.73m2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with moderate and severe head injury
- •patients who underwent computed tomograply angiography of the brain (CTA) at admission to the UKC Ljubljana Emergency Center or during CIT treatment
- •patients with intra-parenchymal intracranial pressure monitor electrode (ICP) installed
排除标准
- •patients with primary decompression craniectomy
- •radiological signs of progression of intracranial hematomas
- •barbiturate coma
- •patients with a norepinephrine dose greater than 0.2 mcg/kg/min
- •pregnant women
- •known hypersensitivity to iodine contrast media and local anesthetics
- •poor renal function (estimated glomerular filtration below 30ml / min / 1.73m2).
结局指标
主要结局
Change in diameter of the cerebral arteries
时间窗: First measurement of the diameter will be done on the CTA made during the first week of hospitalization. Control measurement will be done 1 hour after the BSG.
Diameters of the cerebral arteries will be measured in millimeters (mm) on the CTA before and after BSG. Measurement of the diameter will be done on standard positions: middle third of M1 segment and upper part of M2 segment of middle cerebral artery, middle third of A1 and A2 segment of anterior cerebral artery, P1 segment and first part of P2 segment of posterior cerebral artery, terminal part of internal carotid artery, middle third of the intradural part of vertebral artery and middle third of basilar artery.
次要结局
- Change of systolic velocity (sV) on transcranial Doppler ultrasound(Measurement will be made one hour before and one hour after the BSG.)
- Change of pulsatiloty index on transcranial Doppler ultrasound(Measurement will be made one hour before and one hour after the BSG.)
- Change of the brain tissue oxygenation.(Measurements will be made before and 5, 10, 15, 20, 25, 30 minutes after the BSG.)
- Change in concentration of plasma interleucin 6 (IL-6).(Blood samples will be taken 1 hour before BSG. Next samples 1, 6, 12, 24 hours after the BSG.)
- Change in concentration of plasma protein S100B (S100B).(Blood samples will be taken 1 hour before BSG. Next samples 1, 6, 12, 24 hours after the BSG.)
- Change in concentration of plasma glial fibrillary acidic protein (GFAP).(Blood samples will be taken 1 hour before BSG. Next samples 1, 6, 12, 24 hours after the BSG.)
- Change of mean transition time (MTT) on perfusion computed tomography.(Indicators will be measured 1 hour after the BSG)
- Change of the ICP.(Measurement will be done before and every minute in the next 12 hours after the BSG.)
- Change of regional cerebral blood flow (rCBF) on perfusion computed tomography.(Measurement will be measured 1 hour after the BSG)
- Change of regional cerebral blood volume (rCBV) on perfusion computed tomography.(Measurement will be measured 1 hour after the BSG)
- Change of diastolic velocity (dV) on transcranial Doppler ultrasound(Measurement will be made one hour before and one hour after the BSG.)
- Change in concentration of plasma neuron specific enolase (NSE).(Blood samples will be taken 1 hour before BSG. Next samples 1, 6, 12, 24 hours after the BSG.)
研究者
Ivan Kostadinov
asist Ivan Kostadinov, dr.med.EDRA
University Medical Centre Ljubljana