Acute Cardiac Responses to Spinal Cord Injury
Acute Hemodynamic and Cardiac Responses to Spinal Cord Injury: A Feasibility Study
研究概览
地位
条件
详细说明
Background:
The hemodynamic management of the cervical/high-thoracic spinal cord injured patient represents a remarkably complex clinical scenario, but represents one of the only potentially neuroprotective therapeutic options currently available to the clinician. Presently, the singular goal of hemodynamic management is to increase mean arterial blood pressure (MAP) to 85mmHg by targeting peripheral tone via vasopressor therapy, with a view to increasing perfusion of the spinal cord, preventing ischemia at the injury site, and optimizing neurological outcome. It is often overlooked that the instantaneous removal of descending sympathetic control at the time of SCI renders not only the vast majority of the systemic vasculature devoid of supraspinal input, but it also impairs descending control of the heart. What is yet to be considered in current hemodynamic management protocols is that immediate cardiac dysfunction secondary to impaired supraspinal control of the heart may very well be a significant contributor to poor spinal cord perfusion. Indeed, data collected over the last four years in rodent SCI models suggests that cardiac sympathetic decentralization is the principal cause of the low cardiac output observed in both rodents and people with chronic SCI. As such, the investigator's initiative is to provide a novel approach to hemodynamic management to a porcine model that harnesses both peripheral tone and cardiac function. The investigators believe this approach is an immediately translatable neuroprotective strategy for acute SCI.
Overview:
10 individuals aged 18-60 who have sustained an acute traumatic SCI (above T2 spinal level) less than 72 hours prior will be recruited over a period of 2 years. Recruitment will be isolated to those individuals who already have a central venous catheter and arterial line as part of standard clinical care (which actually occurs in most patients). In addition to standard clinical lines, an esophageal Doppler probe will be placed to measure aortic outflow on which beat-by-beat systolic cardiac function (i.e., stroke volume, cardiac output, ejection fraction) can be estimated. During a 120 min monitoring period, beat-by-beat dependent cardiac indices will be recorded and a modified Starling curve will be constructed by examining relationships between central venous pressure (i.e., an index of venous return) and aortic flow (i.e., an index of cardiac output). After 1hr of monitoring (Part A), a 250ml bolus of intravenous crystalloid will be infused over a 5 min period and measure beat-by-beat central venous pressure and aortic flow (stroke volume) responses (Part B). The primary outcomes are daily resting stroke volume and ejection fraction, change in stroke volume and central venous pressure (CVP) in response to fluid challenge. The secondary outcome is the slope of the Starling curve
研究类型
注册 (预期的)
联系人和位置
学习地点
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Vancouver、加拿大
- 招聘中
- Vancouver General Hospital
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接触:
- Leilani Reichl
- 邮箱:Leilani.Reichl@vch.ca
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Male or Female aged 18-60yrs
- Acute traumatic SCI at T2 or above within the last 72 hours
- Complete (American Spinal Injuries Association Impairment Scale (AIS) A) or incomplete (AIS B) initial designation
- Requires insertion of central venous catheter and arterial catheter as part of standard clinical care
- Able to communicate in English and provide informed consent
- in sinus rhythm.
Exclusion Criteria:
- History and/or symptoms of cardiovascular disease or cardiopulmonary problems/disease, including controlled/uncontrolled hypertension
- Historical or current nasal injury (incl. cosmetic surgery)
- Nasal polyps
- Concurrent facial trauma
- Traumatic brain injury
- Concurrent intra-aortic balloon pump
- Carcinoma/major surgery of the pharynx, larynx or esophagus
- Aneurysms of the thoracic aorta
- Tissue necrosis of the esophagus or nasal passage
- Any other medical condition that in the investigator's opinion would render the study procedures dangerous.
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
daily resting ejection fraction
大体时间:up to 3 days
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Index of systolic cardiac function
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up to 3 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
slope of the Starling curve
大体时间:up to 3 days
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Slope of the central venous pressure vs. cardiac output curve derived from the fluid challenge
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up to 3 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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