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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
Sponsor:
Information provided by (Responsible Party):
Ana Stevanovic, RWTH Aachen University

Brief Summary:

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

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.
Procedure: Elective cardiac surgery
Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Identification of anticholinergic concomitant medication according to the PRISCUS list [ Time Frame: 1 day ]
    Number of participants with preoperative anticholinergic medication

  3. 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)

  4. 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)

  5. 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

  6. Inflammatory markers [ Time Frame: 5 days ]
    Correlation of AChE and BuChE activity to inflammatory markers in serum and the influence on postoperative delirium

  7. 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

  8. 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

  9. 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.

  10. 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

  11. 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


Other Outcome Measures:
  1. 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

  2. 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.

  3. Postoperative bleeding [ Time Frame: 1 day ]
    Measured 12 hours after surgery


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tertiary care clinic
Criteria

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

Information from the National Library of Medicine

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


Locations
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Germany
Department of Anesthesiology, University Hospital Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Principal Investigator: Ana Stevanovic, MD Department of Anesthesiology, University Hospital Aachen, Germany
Publications:

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Responsible Party: Ana Stevanovic, Dr. Ana Stevanovic, RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02631304    
Other Study ID Numbers: 15-162
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Keywords provided by Ana Stevanovic, RWTH Aachen University:
Postoperative delirium
Cholinesterase activity
Buturylcholinesterase activity
Acetylcholinesterase activity
Elderly patients
Cardiac surgery
Additional relevant MeSH terms:
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Delirium
Postoperative Complications
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Pathologic Processes