Clinical trial NCT03060174: Study of Prevention of Postoperative Delirum to Reduce Incidence of Postoperative Cognitive Dysfunction
Official title: The Influence of Non-medication-based Prophylaxis of Postoperative Delirium on Postoperative Delirium and Cognitive Deficit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Postoperative Delirium
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 638
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: postoperative cognitive deficit (POCD)
timeFrame: change from baseline in cognitive function at day 7, 3 months and 1 year after operation
Secondary outcomes:
measure: incidence and severity of postoperative delirium
timeFrame: from the day of operation until the 7th postoperative day
measure: number of patients with cardiac complications
timeFrame: day of operation until 7th postoperative day
measure: length of hospital stay
timeFrame: from day of admission until day of discharge, up to 24 weeks
measure: mortality
timeFrame: 1 year
measure: health related quality of life
timeFrame: 3 months, 1 year after operation
measure: number of patients with respiratory complications
timeFrame: day of operation until 7th postoperative day
measure: number of patients with renal complications
timeFrame: day of operation until 7th postoperative day
measure: number of patients with complications in the immunosystem
timeFrame: day of operation until 7th postoperative day
Other outcomes:
measure: anxiety and depressive symptoms on HADS-D
timeFrame: 7 days, 3 months, 1 year after operation
measure: postoperative pain scores on the numeric rating scale (NRS)
timeFrame: day of operation until 7th postoperative day, 3 months, 1 year after operation
measure: haemoglobin (Anaemia) on a score
timeFrame: intraoperative
measure: blood loss
timeFrame: intraoperative
Locations:
city: Hamburg
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner
Study officials:
References: