Postoperative Cognitive Dysfunction, Postoperative Delirium
Conditions
Brief summary
Postoperative cognitive dysfunction 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, but in some cases may be permanent. The aetiology is multifactorial. One risk factor for developing POCD is the occurrence of postoperative delirium. A total of 638 consecutive patients will be enrolled in the study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The cognitive function will be tested and compared to tests done before surgery. Postoperatively (from the day of operation until the 7th day and except of day 6) the grade of sedation; agitation; signs of delirium; pain; cardiac; respiratory; renal and infectious complications will be recorded. As possible influencing factors, the investigators will document diagnosed depression; comorbidities; intraoperative blood loss; length of hospital stay; 1-year-mortality; number of operations/anaesthetics undergone after the initial operation. Parameters that could trigger either depressive symptoms, neurocognitive dysfunction, anxiety, fatigue or lack of concentration will be recorded. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate, cortisone therapy and adrenal cortical insufficiency.
Detailed description
The methods include a neuropsychological test battery: TAP 2.3 (attention), Trail Making Test (TMT )A+B (attention), Digit span (memory), (Visual Learning and Memory Test (VLMT) (memory), Regensburgerwortfluessigkeitstest/fluency (RWT) subtests (executive function), Mehrfach-Wortschatz-Intelligenztest/vocabulary (MWT-B) (premorbid IQ). Other measures are Hospital Anxiety and Depression Scale (HADS-D) (depressive symptoms and anxiety), Mini Mental State Examination (MMSE) 2 (dementia), Confusion Assessment Method (CAM-ICU) (delirium), Richmond Agitation and Sedation Scale (RASS) (sedation and agitation), Numeric Rating Scale (NRS) (pain) and Short Form Health Survey (SF-12) (health related quality of life).
Interventions
OTHERmonitoring and non-medical prophylaxis of delirium
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 60 years * Cardiac surgery (on-pump/off-pump, standard/minimal invasive) * Written informed patient's consent
Exclusion criteria
* Non-German speaking or not their first language * Illiteracy * Mental disability * Non-corrigible vision impairment * Non-corrigible hearing impairment * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative cognitive deficit (POCD) | change from baseline in cognitive function at day 7, 3 months and 1 year after operation | measured by neuropsychological test battery, analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay | from day of admission until day of discharge, up to 24 weeks | — |
| health related quality of life | 3 months, 1 year after operation | Short Form Health Survey (SF-12) |
| number of patients with respiratory complications | day of operation until 7th postoperative day | daily documentation of pulmonary complications (pneumonia, pulmonary oedema, others), |
| number of patients with renal complications | day of operation until 7th postoperative day | daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis) |
| number of patients with complications in the immunosystem | day of operation until 7th postoperative day | daily documentation of parameters mirroring the immune answer (C-reactive protein, leukocytes, procalcitonin) |
| incidence and severity of postoperative delirium | from the day of operation until the 7th postoperative day | measured 3 times per day via CAM-ICU |
| number of patients with cardiac complications | day of operation until 7th postoperative day | daily documentation of cardiac complications (central venous oxygen saturation, myocardial infarction, acute heart failure, others) |
| mortality | 1 year | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| haemoglobin (Anaemia) on a score | intraoperative | Score Hb \< 6 g/dl, 6-7.99 g/dl, 8-9.99 g/dl, \> 9.99 g/dl |
| blood loss | intraoperative | estimated blood loss in milliliter |
| anxiety and depressive symptoms on HADS-D | 7 days, 3 months, 1 year after operation | The Hospital Anxiety and Depression Scale (HADS-D) is used to measure depressive symptoms. The 7 items are answered on a 4-point scale from 0 to 3 with a scale score varying between 0 and 21 (0-7 = normal, 8-10 = borderline, 11-14 = severe depressive symptoms, \>15 very severe depressive symptoms). |
| postoperative pain scores on the numeric rating scale (NRS) | day of operation until 7th postoperative day, 3 months, 1 year after operation | scale |
Countries
Germany
Outcome results
None listed