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NCT Number: NCT02631304

Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity

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.

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Key information

Conditions

Postoperative Complications Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elective Cardiac Surgery

Procedure

Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity Measured by Point of Care Method - a Prospective Observational Study

Acronym: DECCEP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2015
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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