Clinical trial NCT02210312: Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction
Official title: Are Preoperative Depressive Symptoms Predictive for Postoperative Dysfunction in Non-cardiac Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Postoperative Delirium
Depressive Symptoms
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female and male patients, aged 60 years and older undergoing elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia. To correct for practice effects and conduct additional comparisons, 80 healthy controls will be enrolled and assessed at the same time points (neuropsychological tests and questionnaires).

Brief summary: Postoperative cognitive dysfunction (POCD) 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. In some cases, changes are permanent.

Detailed description: The aetiology of POCD is multifactorial. One described risk factor is preoperative existing depressive symptoms in patients undergoing cardiac surgery.

A total of 300 consecutive patients and 80 healthy controls will be enrolled in this study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The co gnitive function will be tested and compared to tests done before surgery. Postoperatively - from the day of operation until the 7th day (except day 6) - grade of sedation, agitation, signs of delirium, pain, cardiac, respiratory, renal and infectious complications will be monitored.

Next to preoperative depressive symptoms we will also evaluate a diagnosed depression, anxiety, pain, health-related quality of life, physical comorbidities, adrenal cortical insufficiency, type of anaesthesia, intraoperative blood loss, organ complications, postoperative delirium, baseline cognitive functioning and the number of operations/anaesthetics in the study period after the initial operation as further potential predictors of POCD.

In addition, laboratory values and certain medications will be documented. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate and cortisone therapy.

Eligibility criteria: Inclusion Criteria for patients and healthy controls:

* Age \> 60 years
* Written informed patient's consent

Additional Inclusion Criteria for patients:

* Elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia
* Minimum of duration of operation 120 minutes
* Baseline testing 3-14 days preoperatively

Additional Inclusion Criteria for healthy controls:

* matched for age, gender and education
* no surgery over the study period

Exclusion Criteria for patients and healthy control:

* German not mother tongue
* Illiteracy
* Mental disability
* Vision impairment not correctable
* Hearing impairment not correctable
* 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: Frequency of occurrence of early POCD
timeFrame: 7 days
measure: Frequency of occurrence of intermediate POCD
timeFrame: 3 months
measure: Frequency of occurrence of late POCD
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of occurrence of postoperative delirium
timeFrame: 7th postoperative day
measure: Rate of organ complications (cardiac, respiratory, renal)
timeFrame: day of operation until 7th postoperative day
measure: Hospital length of stay
timeFrame: day of admission until day of discharge, up to 24 weeks
measure: Mortality
timeFrame: 1 year
measure: Health related quality of life
timeFrame: 7 days, 3 months, 1 year after operation
Other outcomes:
measure: Dementia
timeFrame: Change from baseline sum score on the Mini-Mental State Examination (2nd ed.) [Time Frame: Before operation to 7 days, 3 months and 1 year after operation].
measure: Preoperative depressive symptoms and anxiety
timeFrame: Baseline
measure: Past or present diagnosed depression
timeFrame: Baseline
measure: Pre- and perioperative pain
timeFrame: Baseline and interval from day of operation to day 7 after operation
measure: Premorbid Intelligence
timeFrame: Baseline
measure: Preoperative cognitive functioning
timeFrame: Baseline
measure: Postoperative depressive symptoms and anxiety
timeFrame: 7 days, 3 months
measure: Change in depressive symptoms and anxiety from baseline to 1 year
timeFrame: Change from baseline scale scores on the HADS depression and anxiety subscales [Time Frame: Before operation to 7 days, 3 months and 1 year after operation].
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:
affiliation: Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf
name: Julia Wiede, MD
role: PRINCIPAL_INVESTIGATOR
References: