<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02210312</url>
  </required_header>
  <id_info>
    <org_study_id>PV4646</org_study_id>
    <nct_id>NCT02210312</nct_id>
  </id_info>
  <brief_title>Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction</brief_title>
  <acronym>DeprPOCD</acronym>
  <official_title>Are Preoperative Depressive Symptoms Predictive for Postoperative Dysfunction in Non-cardiac Surgery?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions&#xD;
      such as attention, perception, concentration, learning, abstract thinking and problem solving&#xD;
      are impaired postoperatively. These changes can be resolved after weeks and months. In some&#xD;
      cases, changes are permanent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aetiology of POCD is multifactorial. One described risk factor is preoperative existing&#xD;
      depressive symptoms in patients undergoing cardiac surgery.&#xD;
&#xD;
      A total of 300 consecutive patients and 80 healthy controls will be enrolled in this study.&#xD;
      Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The co gnitive&#xD;
      function will be tested and compared to tests done before surgery. Postoperatively - from the&#xD;
      day of operation until the 7th day (except day 6) - grade of sedation, agitation, signs of&#xD;
      delirium, pain, cardiac, respiratory, renal and infectious complications will be monitored.&#xD;
&#xD;
      Next to preoperative depressive symptoms we will also evaluate a diagnosed depression,&#xD;
      anxiety, pain, health-related quality of life, physical comorbidities, adrenal cortical&#xD;
      insufficiency, type of anaesthesia, intraoperative blood loss, organ complications,&#xD;
      postoperative delirium, baseline cognitive functioning and the number of&#xD;
      operations/anaesthetics in the study period after the initial operation as further potential&#xD;
      predictors of POCD.&#xD;
&#xD;
      In addition, laboratory values and certain medications will be documented. These include:&#xD;
      anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular&#xD;
      filtration rate and cortisone therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of occurrence of early POCD</measure>
    <time_frame>7 days</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of occurrence of intermediate POCD</measure>
    <time_frame>3 months</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of occurrence of late POCD</measure>
    <time_frame>1 year</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of occurrence of postoperative delirium</measure>
    <time_frame>7th postoperative day</time_frame>
    <description>measured twice per day: Confusion Assessment Method (CAM-ICU) and Richmond Agitation and Sedation Scale (RASS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of organ complications (cardiac, respiratory, renal)</measure>
    <time_frame>day of operation until 7th postoperative day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>day of admission until day of discharge, up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>7 days, 3 months, 1 year after operation</time_frame>
    <description>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]</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dementia</measure>
    <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].</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Preoperative depressive symptoms and anxiety</measure>
    <time_frame>Baseline</time_frame>
    <description>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, &gt;=15 = very severe symptoms).</description>
  </other_outcome>
  <other_outcome>
    <measure>Past or present diagnosed depression</measure>
    <time_frame>Baseline</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pre- and perioperative pain</measure>
    <time_frame>Baseline and interval from day of operation to day 7 after operation</time_frame>
    <description>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]</description>
  </other_outcome>
  <other_outcome>
    <measure>Premorbid Intelligence</measure>
    <time_frame>Baseline</time_frame>
    <description>Multiple-Choice Vocabulary Intelligence Test (MWT-B, sum score)</description>
  </other_outcome>
  <other_outcome>
    <measure>Preoperative cognitive functioning</measure>
    <time_frame>Baseline</time_frame>
    <description>Global mean z-score on the neuropsychological test battery</description>
  </other_outcome>
  <other_outcome>
    <measure>Postoperative depressive symptoms and anxiety</measure>
    <time_frame>7 days, 3 months</time_frame>
    <description>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]</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in depressive symptoms and anxiety from baseline to 1 year</measure>
    <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].</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <condition>Postoperative Delirium</condition>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>elective non-cardiac surgery and non-neurosurgical procedures</arm_group_label>
    <description>300 Patients aged 60 years and older undergoing elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia with a duration of operation of 120 minutes or longer. 80 age-, gender- and education-matched healthy controls.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Female and male patients, aged 60 years and older undergoing elective non-cardiac surgery&#xD;
        and non-neurosurgical procedures in general anaesthesia or combined general/regional&#xD;
        anaesthesia. To correct for practice effects and conduct additional comparisons, 80 healthy&#xD;
        controls will be enrolled and assessed at the same time points (neuropsychological tests&#xD;
        and questionnaires).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for patients and healthy controls:&#xD;
&#xD;
          -  Age &gt; 60 years&#xD;
&#xD;
          -  Written informed patient's consent&#xD;
&#xD;
        Additional Inclusion Criteria for patients:&#xD;
&#xD;
          -  Elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia&#xD;
             or combined general/regional anaesthesia&#xD;
&#xD;
          -  Minimum of duration of operation 120 minutes&#xD;
&#xD;
          -  Baseline testing 3-14 days preoperatively&#xD;
&#xD;
        Additional Inclusion Criteria for healthy controls:&#xD;
&#xD;
          -  matched for age, gender and education&#xD;
&#xD;
          -  no surgery over the study period&#xD;
&#xD;
        Exclusion Criteria for patients and healthy control:&#xD;
&#xD;
          -  German not mother tongue&#xD;
&#xD;
          -  Illiteracy&#xD;
&#xD;
          -  Mental disability&#xD;
&#xD;
          -  Vision impairment not correctable&#xD;
&#xD;
          -  Hearing impairment not correctable&#xD;
&#xD;
          -  Illegal substance abuse (current or past history)&#xD;
&#xD;
          -  Alcohol abuse (current or past history)&#xD;
&#xD;
          -  Chronic benzodiazepine use&#xD;
&#xD;
          -  Psychosis (current or past history)&#xD;
&#xD;
          -  Parkinson Disease&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Multiple sclerosis&#xD;
&#xD;
          -  Epilepsy (current or past history)&#xD;
&#xD;
          -  Cerebral tumor (current or past history)&#xD;
&#xD;
          -  Apoplexy or intracranial bleeding (current or past history)&#xD;
&#xD;
          -  Severe traumatic brain injury (current or past history)&#xD;
&#xD;
          -  Severe liver disease (Child Pugh B, C, liver insufficiency)&#xD;
&#xD;
          -  Severe kidney disease with dialysis&#xD;
&#xD;
          -  Mini Mental Status Examination &lt; 24 points&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Wiede, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>June 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>April 28, 2019</last_update_submitted>
  <last_update_submitted_qc>April 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergence Delirium</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210312
org study id: PV4646
nct id: NCT02210312
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Frequency of occurrence of early POCD
time frame: 7 days
description: 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)
measure: Frequency of occurrence of intermediate POCD
time frame: 3 months
description: 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)
measure: Frequency of occurrence of late POCD
time frame: 1 year
description: 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)
measure: Frequency of occurrence of postoperative delirium
time frame: 7th postoperative day
description: measured twice per day: Confusion Assessment Method (CAM-ICU) and Richmond Agitation and Sedation Scale (RASS)
measure: Rate of organ complications (cardiac, respiratory, renal)
time frame: day of operation until 7th postoperative day
measure: Hospital length of stay
time frame: day of admission until day of discharge, up to 24 weeks
measure: Mortality
time frame: 1 year
measure: Health related quality of life
time frame: 7 days, 3 months, 1 year after operation
description: 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]
measure: 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].
measure: Preoperative depressive symptoms and anxiety
time frame: Baseline
description: 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).
measure: Past or present diagnosed depression
time frame: Baseline
description: 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.
measure: Pre- and perioperative pain
time frame: Baseline and interval from day of operation to day 7 after operation
description: 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]
measure: Premorbid Intelligence
time frame: Baseline
description: Multiple-Choice Vocabulary Intelligence Test (MWT-B, sum score)
measure: Preoperative cognitive functioning
time frame: Baseline
description: Global mean z-score on the neuropsychological test battery
measure: Postoperative depressive symptoms and anxiety
time frame: 7 days, 3 months
description: 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]
measure: 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].
arm group label: elective non-cardiac surgery and non-neurosurgical procedures
description: 300 Patients aged 60 years and older undergoing elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia with a duration of operation of 120 minutes or longer. 80 age-, gender- and education-matched healthy controls.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Julia Wiede, MD
role: Principal Investigator
affiliation: Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Emergence Delirium
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
mesh term: Depression