Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction

Phase

N/A

Condition

Mild Cognitive Impairment

Memory Problems

Mental Disability

Treatment

N/A

Clinical Study ID

NCT02210312

PV4646

Ages > 60
All Genders
Accepts Healthy Volunteers

Study Summary

Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months. In some cases, changes are permanent.

Eligibility Criteria

Inclusion

Inclusion Criteria for patients and healthy controls:

Age > 60 years
Written informed patient's consent

Additional Inclusion Criteria for patients:

Elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia
Minimum of duration of operation 120 minutes
Baseline testing 3-14 days preoperatively

Additional Inclusion Criteria for healthy controls:

matched for age, gender and education
no surgery over the study period

Exclusion Criteria for patients and healthy control:

German not mother tongue
Illiteracy
Mental disability
Vision impairment not correctable
Hearing impairment not correctable
Illegal substance abuse (current or past history)
Alcohol abuse (current or past history)
Chronic benzodiazepine use
Psychosis (current or past history)
Parkinson Disease
Dementia
Multiple sclerosis
Epilepsy (current or past history)
Cerebral tumor (current or past history)
Apoplexy or intracranial bleeding (current or past history)
Severe traumatic brain injury (current or past history)
Severe liver disease (Child Pugh B, C, liver insufficiency)
Severe kidney disease with dialysis
Mini Mental Status Examination < 24 points

Study Design

May 01, 2014

October 31, 2018

Study Description

The aetiology of POCD is multifactorial. One described risk factor is preoperative existing depressive symptoms in patients undergoing cardiac surgery.

A total of 300 consecutive patients and 80 healthy controls will be enrolled in this study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The co gnitive function will be tested and compared to tests done before surgery. Postoperatively - from the day of operation until the 7th day (except day 6) - grade of sedation, agitation, signs of delirium, pain, cardiac, respiratory, renal and infectious complications will be monitored.

Next to preoperative depressive symptoms we will also evaluate a diagnosed depression, anxiety, pain, health-related quality of life, physical comorbidities, adrenal cortical insufficiency, type of anaesthesia, intraoperative blood loss, organ complications, postoperative delirium, baseline cognitive functioning and the number of operations/anaesthetics in the study period after the initial operation as further potential predictors of POCD.

In addition, laboratory values and certain medications will be documented. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate and cortisone therapy.

Connect with a study center

Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner
Hamburg, 20246
Germany
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