Study of Prevention of Postoperative Delirum to Reduce Incidence of Postoperative Cognitive Dysfunction
- Conditions
- Postoperative DeliriumPostoperative Cognitive Dysfunction
- Interventions
- Other: monitoring and non-medical prophylaxis of delirium
- Registration Number
- NCT03060174
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 638
- Age > 60 years
- Cardiac surgery (on-pump/off-pump, standard/minimal invasive)
- Written informed patient's consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description monitoring and non-medical prophylaxis of delirium monitoring and non-medical prophylaxis of delirium 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 cardiac complications day of operation until 7th postoperative day daily documentation of cardiac complications (central venous oxygen saturation, myocardial infarction, acute heart failure, others)
length of hospital stay from day of admission until day of discharge, up to 24 weeks mortality 1 year 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 renal complications day of operation until 7th postoperative day daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis)
Trial Locations
- Locations (1)
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, Germany