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
NCT Number: NCT02210312
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.
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Notify Me60 year and older
All sexes
Observational
Hamburg, 20246, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients and healthy controls:
Additional Inclusion Criteria for patients:
Additional Inclusion Criteria for healthy controls:
Exclusion criteria
for patients and healthy control:
Time frame: 7 days
POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)
Time frame: 3 months
POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)
Time frame: 1 year
POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)
Time frame: 7th postoperative day
measured twice per day: Confusion Assessment Method (CAM-ICU) and Richmond Agitation and Sedation Scale (RASS)
Time frame: day of operation until 7th postoperative day
Time frame: day of admission until day of discharge, up to 24 weeks
Time frame: 1 year
Time frame: 7 days, 3 months, 1 year after operation
Time Frame: 7 days after operation [Measure: Short Form-12 Health Survey: Item General Health] Time Frame: 3 months after operation [Measure: Short Form-12 Health Survey: Physical and mental health summary measures] Time Frame: 1 year after operation [Measure: Short Form-12 Health Survey: Physical and mental health summary measures]
Time frame: Change from baseline sum score on the Mini-Mental State Examination (2nd ed.) [Time Frame: Before operation to 7 days, 3 months and 1 year after operation].
Time frame: Baseline
Preoperative depressive symptoms and anxiety are assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS comprises 14 Items and 2 subscales with 7 items each. The items are answered on a 4-point rating scale from 0 to 3 with a scale score varying between 0 and 21. Higher scores represent higher distress (cut-off- scores: 0-7 = normal, 8-10 = borderline, 11-14 = severe symptoms, >=15 = very severe symptoms).
Time frame: Baseline
A self-administered questionnaire was developed to explore pre-existing depression (current or in past medical history) and its medical or/and non-medical treatment.
Time frame: Baseline and interval from day of operation to day 7 after operation
Preoperative pain: Numerical Rating Scale from 0 to 10 [Time Frame: Baseline] Perioperative pain: Numerical Rating Scale from 0 to 10, averaged over one week [Time Frame: Interval from day of operation to day 7 after operation]
Time frame: Baseline
Multiple-Choice Vocabulary Intelligence Test (MWT-B, sum score)
Time frame: Baseline
Global mean z-score on the neuropsychological test battery
Time frame: 7 days, 3 months
HADS, depression scale score [Time Frame: 7 days and 3 months after operation] HADS, anxiety scale score [Time Frame: 7 days and 3 months after operation]
Time frame: Change from baseline scale scores on the HADS depression and anxiety subscales [Time Frame: Before operation to 7 days, 3 months and 1 year after operation].
Universitätsklinikum Hamburg-Eppendorf
Other
Are Preoperative Depressive Symptoms Predictive for Postoperative Dysfunction in Non-cardiac Surgery?
Acronym: DeprPOCD
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