DelPOCD: Study of Prevention of Postoperative Delirum to Reduce Incidence of Postoperative Cognitive Dysfunction
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Other: monitoring and non-medical prophylaxis of delirium
|
| No Intervention: Standard 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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)
- length of hospital stay [from day of admission until day of discharge, up to 24 weeks]
- mortality [1 year]
- 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)
Other Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 60 years
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Cardiac surgery (on-pump/off-pump, standard/minimal invasive)
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Written informed patient's consent
Exclusion Criteria:
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Non-German speaking or not their first language
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Illiteracy
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Mental disability
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Non-corrigible vision impairment
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Non-corrigible hearing impairment
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Illegal substance abuse (current or past history)
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Alcohol abuse (current or past history)
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Chronic benzodiazepine use
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Psychosis (current or past history)
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Parkinson Disease
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Dementia
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Multiple sclerosis
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Epilepsy (current or past history)
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Cerebral tumor (current or past history)
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Apoplexy or intracranial bleeding (current or past history)
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Severe traumatic brain injury (current or past history)
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Severe liver disease (Child Pugh B, C, liver insufficiency)
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Severe kidney disease with dialysis
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Mini Mental Status Examination < 24 points
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | 20246 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PV4654