Study of Prevention of Postoperative Delirum to Reduce Incidence of Postoperative Cognitive Dysfunction

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Influence of Non-medication-based Prophylaxis of Postoperative Delirium on Postoperative Delirium and Cognitive Deficit

Conditions
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Postoperative Cognitive Dysfunction, Postoperative Delirium

Intervention / Treatment
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* Other: monitoring and non-medical prophylaxis of delirium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: monitoring and non-medical prophylaxis of delirium<br>The treatment group will receive monitoring and prophylaxis of delirium. The study arm designed to prevent delirium incorporates reorientation (watches, calendar, family photos, use of hearing aids, glasses and dentures, cognitive stimulation (newspaper, magazines, radio, television), early mobilisation, early enteral nutrition, early removal of drains or catheters, normalizing sleep-awake-rhythm. | Other: monitoring and non-medical prophylaxis of delirium<br> <br> |
| No Intervention: Standard<br>The standard group will receive standard monitoring and standard treatment. The indication, choice and dosage of the medication used to treat delirium will be at the discretion of the ward doctor and will not be influenced by this study. The chosen medication as well as its dosage will be documented. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative cognitive deficit (POCD) | measured by neuropsychological test battery, analysis | change from baseline in cognitive function at day 7, 3 months and 1 year after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and severity of postoperative delirium | measured 3 times per day via CAM-ICU | from the day of operation until the 7th postoperative day | 
| number of patients with cardiac complications | daily documentation of cardiac complications (central venous oxygen saturation, myocardial infarction, acute heart failure, others) | day of operation until 7th postoperative day | 
| length of hospital stay |  | from day of admission until day of discharge, up to 24 weeks | 
| mortality |  | 1 year | 
| health related quality of life | Short Form Health Survey (SF-12) | 3 months, 1 year after operation | 
| number of patients with respiratory complications | daily documentation of pulmonary complications (pneumonia, pulmonary oedema, others), | day of operation until 7th postoperative day | 
| number of patients with renal complications | daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis) | day of operation until 7th postoperative day | 
| number of patients with complications in the immunosystem | daily documentation of parameters mirroring the immune answer (C-reactive protein, leukocytes, procalcitonin) | day of operation until 7th postoperative day |