Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction

Depressive Symptoms Clinical Trial

— DeprPOCD  

Official title:

Are Preoperative Depressive Symptoms Predictive for Postoperative Dysfunction in Non-cardiac Surgery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210312
• Other study ID #: PV4646
• Status: Completed
• Start date: May 2014
• Est. completion date: October 2018

Study information

• Verified date: April 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Depression
• Depressive Symptoms
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dementia		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].
Other	Preoperative depressive symptoms and anxiety	Preoperative depressive symptoms and anxiety are assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS comprises 14 Items and 2 subscales with 7 items each. The items are answered on a 4-point rating scale from 0 to 3 with a scale score varying between 0 and 21. Higher scores represent higher distress (cut-off- scores: 0-7 = normal, 8-10 = borderline, 11-14 = severe symptoms, >=15 = very severe symptoms).	Baseline
Other	Past or present diagnosed depression	A self-administered questionnaire was developed to explore pre-existing depression (current or in past medical history) and its medical or/and non-medical treatment.	Baseline
Other	Pre- and perioperative pain	Preoperative pain: Numerical Rating Scale from 0 to 10 [Time Frame: Baseline] Perioperative pain: Numerical Rating Scale from 0 to 10, averaged over one week [Time Frame: Interval from day of operation to day 7 after operation]	Baseline and interval from day of operation to day 7 after operation
Other	Premorbid Intelligence	Multiple-Choice Vocabulary Intelligence Test (MWT-B, sum score)	Baseline
Other	Preoperative cognitive functioning	Global mean z-score on the neuropsychological test battery	Baseline
Other	Postoperative depressive symptoms and anxiety	HADS, depression scale score [Time Frame: 7 days and 3 months after operation] HADS, anxiety scale score [Time Frame: 7 days and 3 months after operation]	7 days, 3 months
Other	Change in depressive symptoms and anxiety from baseline to 1 year		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].
Primary	Frequency of occurrence of early POCD	POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)	7 days
Primary	Frequency of occurrence of intermediate POCD	POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)	3 months
Primary	Frequency of occurrence of late POCD	POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function)	1 year
Secondary	Frequency of occurrence of postoperative delirium	measured twice per day: Confusion Assessment Method (CAM-ICU) and Richmond Agitation and Sedation Scale (RASS)	7th postoperative day
Secondary	Rate of organ complications (cardiac, respiratory, renal)		day of operation until 7th postoperative day
Secondary	Hospital length of stay		day of admission until day of discharge, up to 24 weeks
Secondary	Mortality		1 year
Secondary	Health related quality of life	Time Frame: 7 days after operation [Measure: Short Form-12 Health Survey: Item General Health] Time Frame: 3 months after operation [Measure: Short Form-12 Health Survey: Physical and mental health summary measures] Time Frame: 1 year after operation [Measure: Short Form-12 Health Survey: Physical and mental health summary measures]	7 days, 3 months, 1 year after operation