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

NCT ID: NCT02631304

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-11-30

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.

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.

Conditions

Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Elective cardiac surgery

Intervention Type: PROCEDURE

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

Interventions

Elective cardiac surgery

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Ana Stevanovic

Dr. Ana Stevanovic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Stevanovic, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, University Hospital Aachen, Germany

Locations

Department of Anesthesiology, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

References

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Reference Type: BACKGROUND

PMID: 23887126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21576115 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 20345866 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 23992774 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24557038 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24479557 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24395570 (View on PubMed)

Other Identifiers

15-162

Identifier Type: -

Identifier Source: org_study_id