Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity (DECCEP)
2018年4月10日 更新者:Ana Stevanovic、RWTH Aachen University
Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity Measured by Point of Care Method - a Prospective Observational Study
The purpose of this study is to assess the association between the "point-of-care" (POC) measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and postoperative delirium in elderly patients undergoing cardiac surgery.
Furthermore the investigators aim to identify factors, which influence the baseline levels and the time course of ChE activity.
研究概览
详细说明
Cardiac surgery in elderly patients is associated with serious complications, like increased morbidity, mortality and postoperative delirium with further hazardous consequences.
The incidence of postoperative delirium in elderly is reported with a range from 36.6% - 54.9%.
The pathophysiology of delirium is complex and the interaction of the cholinergic system and inflammation reaction is a relevant precipitant factor.
It was suggested that there is a strong association between the perioperative plasma ChE activity and the inflammatory response in patients developing delirium.
Patients showed a significant reduction of the total ChE activity after orthopaedic surgery, with significant lower pre- and postoperative values of AChE and BuChE and increased inflammatory response in patients developing postoperative delirium.
It remains unclear if these results are applicable to other patient populations and which factors have influenced the low preoperative ChE levels.
In patients suffering from a cardiac disease, a reduced total ChE respectively BuChE activity was significantly associated with mortality and long-term major adverse cardiovascular events.
The investigators hypothesize that the ChE activity in peripheral blood can be used as a potential biomarker, to early detect patients at high risk for postoperative delirium.
研究类型
观察性的
注册 (预期的)
100
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
-
-
NRW
-
Aachen、NRW、德国、52074
- Department of Anesthesiology, University Hospital Aachen
-
-
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
概率样本
研究人群
Tertiary care clinic
描述
Inclusion Criteria:
- Written informed consent
- ≥ 65 years of age
- Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB
- Both genders
Exclusion Criteria:
- Planned deep hypothermic arrest
- Acute / emergency procedures
- Surgery without extracorporeal circulation (ECC)
- Patients with a history of pseudocholinesterase deficiency
- Employees of the respective study centres
- Illiteracy
- Severe communication difficulties and severe vision or hearing problems
- Patients legally unable to give written informed consent
- non-fluency in German language
- Severe psychiatric or neuropsychiatric disorders
- MMSE < 24 points, short geriatric depression scale (GDS) ≥ 10 points
- Recent (<6 months) history of alcohol or drug abuse
- The participation in a drug or device trial within the previous 30 days
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
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients undergoing cardiac surgery
Elderly patients scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of cardiopulmonary bypass.
|
Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery
|
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 |
|---|---|---|
|
Acetylcholinesterase (AChE) and buturylcholinesterase (BuChE) activity
大体时间:5 days
|
The perioperative AChE and BuChE activity will be assessed in the whole blood by a "point-of-care" measuring instrument (ChE check mobile ®) and the association to the incidence and duration of postoperative delirium will be determined.
It will be assessed preoperative and maximum until the 5th postoperative day (POD), minimum until the 3.POD.
|
5 days
|
|
Delirium
大体时间:5-45 days
|
Postoperative delirium will be assessed preoperative and daily with the CAM / CAM-ICU test until the 5.POD and on the discharge day from hospital.
The incidence of postoperative delirium will be associated with the perioperative AChE and BuChE time course.
|
5-45 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pre-existing patient related risk factors
大体时间:1 day
|
Influence of pre-existing patient related risk factors ( demographic data, medical and surgical history assessed preoperative) on postoperative delirium and the AChE and BuChE activity.
|
1 day
|
|
Identification of anticholinergic concomitant medication according to the PRISCUS list
大体时间:1 day
|
Number of participants with preoperative anticholinergic medication
|
1 day
|
|
Survey of treatment associated data
大体时间:45 days
|
Survey of treatment associated data until discharge (organ dysfunctions, postoperative pain, ICU length of stay, hospital length of stay, duration of mechanical ventilation, readmission rate to ICU, operation time, surgery, anaesthesia, intraoperative and postoperative volume load, postoperative mortality, comorbidities)
|
45 days
|
|
Cognitive function
大体时间:45 days
|
Assessment of the cognitive function preoperative and on 3.POD and at discharge,by mini mental state examination (MMSE)
|
45 days
|
|
Routine venous blood parameters
大体时间:5 days
|
Correlation of AChE and BuChE activity and routine venous blood parameters (Hb, Platelets, Leucocytes, INR, PTT, liver-enzymes (AST, ALT, y-GT, total Bilirubin), Creatinine, BUN, Albumin, sodium and potassium) and the influence on postoperative delirium
|
5 days
|
|
Inflammatory markers
大体时间:5 days
|
Correlation of AChE and BuChE activity to inflammatory markers in serum and the influence on postoperative delirium
|
5 days
|
|
Follow up measure of functional decline according to the IADL scale
大体时间:180 days
|
Patients will be followed up by phone on the 30.
and 180.POD.
Association of AChE and BuChE activity and the functional decline on the 30.
and 180.POD.
The preoperative IADL scale will be compared to the data on the 30.
and 180.POD to assess the functional decline
|
180 days
|
|
Follow up measure of mortality
大体时间:180 days
|
Patients will be followed up by phone on the 30.
and 180.POD.
Determination of the association between the peri-operative AChE and BuChE activity and the mortality on the 30.
and 180.POD
|
180 days
|
|
Follow up measure of the number of MACCE-events
大体时间:180 days
|
Patients will be followed up by phone on the 30.
and 180.POD.
Association of AChE and BuChE activity and the postoperative major adverse cardiovascular and cerebral events (MACCE) on the 30.
and 180.POD.
The number of events will be assessed.
|
180 days
|
|
Health related quality of life
大体时间:180 days
|
Health related quality of life measured by EuroQuol EQ-5D-5L test preoperative, on 30.POD and 180.
POD
|
180 days
|
|
Instrumental activities of daily living
大体时间:180 days
|
The Lawton Instrumental Activities of Daily Living (IADL) Scale measured preoperative, on 30.POD and 180.
POD
|
180 days
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gender effect on delirium assessed by CAM-ICU/CAM
大体时间:5-45 days
|
Analysis of the association of postoperative delirium until 5.POD respective discharge day and the gender of the patient
|
5-45 days
|
|
Gender effects on the peri-operative AChE and BuChE activity
大体时间:5-45 days
|
Measurement of the AChE and BuChE activity until 3.-5.POD.
Analysis of the association of the gender of the patient and the peri-operative time-course of the AChE and BuChE activity until the 3. respective 5.POD.
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5-45 days
|
|
Postoperative bleeding
大体时间:1 day
|
Measured 12 hours after surgery
|
1 day
|
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
- 首席研究员:Ana Stevanovic, MD、Department of Anesthesiology, University Hospital Aachen, Germany
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Smulter N, Lingehall HC, Gustafson Y, Olofsson B, Engstrom KG. Delirium after cardiac surgery: incidence and risk factors. Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):790-6. doi: 10.1093/icvts/ivt323. Epub 2013 Jul 25.
- Cerejeira J, Batista P, Nogueira V, Firmino H, Vaz-Serra A, Mukaetova-Ladinska EB. Low preoperative plasma cholinesterase activity as a risk marker of postoperative delirium in elderly patients. Age Ageing. 2011 Sep;40(5):621-6. doi: 10.1093/ageing/afr053. Epub 2011 May 15.
- Rudolph JL, Inouye SK, Jones RN, Yang FM, Fong TG, Levkoff SE, Marcantonio ER. Delirium: an independent predictor of functional decline after cardiac surgery. J Am Geriatr Soc. 2010 Apr;58(4):643-9. doi: 10.1111/j.1532-5415.2010.02762.x. Epub 2010 Mar 22.
- Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. The immunology of delirium. Neuroimmunomodulation. 2014;21(2-3):72-8. doi: 10.1159/000356526. Epub 2014 Feb 14.
- Distelmaier K, Winter MP, Rutzler K, Heinz G, Lang IM, Maurer G, Koinig H, Steinlechner B, Niessner A, Goliasch G. Serum butyrylcholinesterase predicts survival after extracorporeal membrane oxygenation after cardiovascular surgery. Crit Care. 2014 Jan 30;18(1):R24. doi: 10.1186/cc13711.
- Arbel Y, Shenhar-Tsarfaty S, Waiskopf N, Finkelstein A, Halkin A, Revivo M, Berliner S, Herz I, Shapira I, Keren G, Soreq H, Banai S. Decline in serum cholinesterase activities predicts 2-year major adverse cardiac events. Mol Med. 2014 Feb 12;20(1):38-45. doi: 10.2119/molmed.2013.00139.
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 (实际的)
2015年7月1日
初级完成 (实际的)
2016年5月1日
研究完成 (实际的)
2016年11月1日
研究注册日期
首次提交
2015年12月9日
首先提交符合 QC 标准的
2015年12月11日
首次发布 (估计)
2015年12月16日
研究记录更新
最后更新发布 (实际的)
2018年4月11日
上次提交的符合 QC 标准的更新
2018年4月10日
最后验证
2018年4月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 15-162
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