- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02631304
Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity (DECCEP)
April 10, 2018 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- Department of Anesthesiology, University Hospital Aachen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Tertiary care clinic
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 days
|
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.
|
5-45 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Identification of anticholinergic concomitant medication according to the PRISCUS list
Time Frame: 1 day
|
Number of participants with preoperative anticholinergic medication
|
1 day
|
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)
|
45 days
|
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)
|
45 days
|
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
|
5 days
|
Inflammatory markers
Time Frame: 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
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
|
180 days
|
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
|
180 days
|
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.
|
180 days
|
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
|
180 days
|
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
|
180 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5-45 days
|
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.
|
5-45 days
|
Postoperative bleeding
Time Frame: 1 day
|
Measured 12 hours after surgery
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ana Stevanovic, MD, Department of Anesthesiology, University Hospital Aachen, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
December 9, 2015
First Submitted That Met QC Criteria
December 11, 2015
First Posted (Estimate)
December 16, 2015
Study Record Updates
Last Update Posted (Actual)
April 11, 2018
Last Update Submitted That Met QC Criteria
April 10, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-162
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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