Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity (DECCEP)
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|ClinicalTrials.gov Identifier: NCT02631304|
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : April 11, 2018
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.
|Condition or disease||Intervention/treatment|
|Postoperative Complications||Procedure: Elective cardiac surgery|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity Measured by Point of Care Method - a Prospective Observational Study|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||November 2016|
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.
Procedure: Elective cardiac surgery
Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery
- Acetylcholinesterase (AChE) and buturylcholinesterase (BuChE) activity [ Time Frame: 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.
- Delirium [ Time Frame: 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.
- Pre-existing patient related risk factors [ Time Frame: 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.
- Identification of anticholinergic concomitant medication according to the PRISCUS list [ Time Frame: 1 day ]Number of participants with preoperative anticholinergic medication
- Survey of treatment associated data [ Time Frame: 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)
- Cognitive function [ Time Frame: 45 days ]Assessment of the cognitive function preoperative and on 3.POD and at discharge,by mini mental state examination (MMSE)
- Routine venous blood parameters [ Time Frame: 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
- Inflammatory markers [ Time Frame: 5 days ]Correlation of AChE and BuChE activity to inflammatory markers in serum and the influence on postoperative delirium
- Follow up measure of functional decline according to the IADL scale [ Time Frame: 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
- Follow up measure of mortality [ Time Frame: 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
- Follow up measure of the number of MACCE-events [ Time Frame: 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.
- Health related quality of life [ Time Frame: 180 days ]Health related quality of life measured by EuroQuol EQ-5D-5L test preoperative, on 30.POD and 180. POD
- Instrumental activities of daily living [ Time Frame: 180 days ]The Lawton Instrumental Activities of Daily Living (IADL) Scale measured preoperative, on 30.POD and 180. POD
- Gender effect on delirium assessed by CAM-ICU/CAM [ Time Frame: 5-45 days ]Analysis of the association of postoperative delirium until 5.POD respective discharge day and the gender of the patient
- Gender effects on the peri-operative AChE and BuChE activity [ Time Frame: 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.
- Postoperative bleeding [ Time Frame: 1 day ]Measured 12 hours after surgery
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631304
|Department of Anesthesiology, University Hospital Aachen|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Ana Stevanovic, MD||Department of Anesthesiology, University Hospital Aachen, Germany|