Autonomic Cardiovascular Control for Elderly Surgery Patients
2014年4月14日 更新者：Oslo University Hospital
The purpose of this study is to study aspects of autonomic cardiovascular control and the level of stress hormones and inflammatory markers in saliva or serum, in elderly patients exposed to elective, major abdominal surgery, with or without postoperative delirium, to explore the hypothesis that delirium may be the result of aberrant stress responses.
研究概览
详细说明
Patients admitted for elective, major, abdominal surgery will be tested with a head-up tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative day. Haemodynamic variables will be registered by the device TaskForceMonitor which monitors heart rate (HR), electrocardiography (ECG), blood pressure and stroke volume continuously and non-invasively.
Background variables (including demographics, comorbidity and simple cognitive tests) and daily variables (including delirium assessments) will be registered.
Blood and saliva samples will be drawn preoperatively and postoperatively to measure levels of stress hormones and inflammatory markers.
研究类型
观察性的
注册 (实际的)
3
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Oslo、挪威
- Oslo University Hospital, Ullevaal
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients scheduled for abdominal surgery at Oslo University Hospital.
描述
Inclusion Criteria:
- Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
Exclusion Criteria:
- Absence of a valid informed consent or assent, or consent from a legal proxy
- Patients with atrial fibrillation or a pacemaker rhythm
- Polyneuropathy
- Current treatment with beta-blockers, calcium-blockers or cholinesterase inhibitors
- Competing research project
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Abdominal surgery
Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
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Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
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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 |
|---|---|---|
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Change in orthostatic cardiovascular responses
大体时间：Baseline and postoperatively at surgical ward (expected second postoperative day)
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Change in orthostatic cardiovascular responses (head-up tilt test) pre- and postoperatively in patients with and without postoperative delirium will be evaluated based on measurements of heart rate, systolic blood pressure (BP), mean BP, diastolic BP, stroke index, total peripheral resistance index, end-diastolic volume index, and acceleration index.
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Baseline and postoperatively at surgical ward (expected second postoperative day)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Barthel Activities of Daily Living (ADL) Scale
大体时间：Baseline
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Score from 0-20 points
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Baseline
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Nottingham Extended Activity of Daily Living (NEADL) Scale
大体时间：Baseline
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Score from 0-66 points.
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Baseline
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Cumulative Illness Rating Scale
大体时间：Baseline
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Total score from 0-56.
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Baseline
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Dementia
大体时间：Baseline
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Simple cognitive tests preformed preoperatively, including MMSE, Clock Drawing Test, Trail making A and B and Ten word memory test.
Also IQCODE when reliable information is present.
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Baseline
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Delirium
大体时间：Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.
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Daily assessing the patient using the Confusion Assessment Method (CAM), shortened version.
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Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days.
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Cortisol
大体时间：Baseline and second postoperative day
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Looking for differences in levels of cortisol in saliva (morning samples) pre-and postoperatively in patients developing delirium compared to patients not developing delirium.
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Baseline and second postoperative day
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Severity of delirium
大体时间：Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days
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Daily assessing the patient using MDAS (the memorial delirium assessment scale).
Total score from 0-30.
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Baseline and a minimum of 2 days after the second tilt-test, an expected average of 5 days
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Gait speed
大体时间：Baseline
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Measuring comfortable gait speed at length of 4 meters, best result of 2 tests.
Result in meter per second.
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Baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Torgeir B Wyller, MD, Prof、Oslo University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年10月1日
初级完成 (实际的)
2012年11月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2012年9月27日
首先提交符合 QC 标准的
2012年9月28日
首次发布 (估计)
2012年10月2日
研究记录更新
最后更新发布 (估计)
2014年4月15日
上次提交的符合 QC 标准的更新
2014年4月14日
最后验证
2014年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Abdominal surgery的临床试验
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St. Joseph's Healthcare HamiltonHamilton Academic Health Sciences Organization完全的
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Seoul National University HospitalJohnson & Johnson Medical Companies完全的