Skip to main content
OpenTrials
Completed

NCT Number: NCT02210312

Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Frequency of occurrence of early POCD

    Time frame: 7 days

    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)

  2. Frequency of occurrence of intermediate POCD

    Time frame: 3 months

    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. Frequency of occurrence of late POCD

    Time frame: 1 year

    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)

Secondary outcomes

  1. Frequency of occurrence of postoperative delirium

    Time frame: 7th postoperative day

    measured twice per day: Confusion Assessment Method (CAM-ICU) and Richmond Agitation and Sedation Scale (RASS)

  2. Rate of organ complications (cardiac, respiratory, renal)

    Time frame: day of operation until 7th postoperative day

  3. Hospital length of stay

    Time frame: day of admission until day of discharge, up to 24 weeks

  4. Mortality

    Time frame: 1 year

  5. Health related quality of life

    Time frame: 7 days, 3 months, 1 year after operation

    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]

Other outcomes

  1. Dementia

    Time frame: 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].

  2. Preoperative depressive symptoms and anxiety

    Time frame: Baseline

    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).

  3. Past or present diagnosed depression

    Time frame: Baseline

    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.

  4. Pre- and perioperative pain

    Time frame: Baseline and interval from day of operation to day 7 after operation

    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]

  5. Premorbid Intelligence

    Time frame: Baseline

    Multiple-Choice Vocabulary Intelligence Test (MWT-B, sum score)

  6. Preoperative cognitive functioning

    Time frame: Baseline

    Global mean z-score on the neuropsychological test battery

  7. Postoperative depressive symptoms and anxiety

    Time frame: 7 days, 3 months

    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]

  8. Change in depressive symptoms and anxiety from baseline to 1 year

    Time frame: 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].

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: DeprPOCD

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2014
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.