Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity (DECCEP)
2018년 4월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (예상)
100
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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NRW
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Aachen, NRW, 독일, 52074
- Department of Anesthesiology, University Hospital Aachen
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Tertiary care clinic
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Acetylcholinesterase (AChE) and buturylcholinesterase (BuChE) activity
기간: 5 days
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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.
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5 days
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Delirium
기간: 5-45 days
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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.
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5-45 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pre-existing patient related risk factors
기간: 1 day
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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.
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1 day
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Identification of anticholinergic concomitant medication according to the PRISCUS list
기간: 1 day
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Number of participants with preoperative anticholinergic medication
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1 day
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Survey of treatment associated data
기간: 45 days
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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)
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45 days
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Cognitive function
기간: 45 days
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Assessment of the cognitive function preoperative and on 3.POD and at discharge,by mini mental state examination (MMSE)
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45 days
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Routine venous blood parameters
기간: 5 days
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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
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5 days
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Inflammatory markers
기간: 5 days
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Correlation of AChE and BuChE activity to inflammatory markers in serum and the influence on postoperative delirium
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5 days
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Follow up measure of functional decline according to the IADL scale
기간: 180 days
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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
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180 days
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Follow up measure of mortality
기간: 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
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Follow up measure of the number of MACCE-events
기간: 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.
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180 days
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Health related quality of life
기간: 180 days
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Health related quality of life measured by EuroQuol EQ-5D-5L test preoperative, on 30.POD and 180.
POD
|
180 days
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Instrumental activities of daily living
기간: 180 days
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The Lawton Instrumental Activities of Daily Living (IADL) Scale measured preoperative, on 30.POD and 180.
POD
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180 days
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gender effect on delirium assessed by CAM-ICU/CAM
기간: 5-45 days
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Analysis of the association of postoperative delirium until 5.POD respective discharge day and the gender of the patient
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5-45 days
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Gender effects on the peri-operative AChE and BuChE activity
기간: 5-45 days
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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
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Postoperative bleeding
기간: 1 day
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Measured 12 hours after surgery
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1 day
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Ana Stevanovic, MD, Department of Anesthesiology, University Hospital Aachen, Germany
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 7월 1일
기본 완료 (실제)
2016년 5월 1일
연구 완료 (실제)
2016년 11월 1일
연구 등록 날짜
최초 제출
2015년 12월 9일
QC 기준을 충족하는 최초 제출
2015년 12월 11일
처음 게시됨 (추정)
2015년 12월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 4월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 10일
마지막으로 확인됨
2018년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 15-162
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