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NCT Number: NCT02832193

Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin

Data on prevention of perioperative neurocognitive disorders (pNCDs) are limited. The purpose of this monocentric parallel - grouped observational registry is to collect study data from studies with pNCDs as primary or secondary endpoint to estimate prevalence and incidence of pNCDs.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany

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About this study

Perioperative cognitive trajectories (Perioperative neurocognitive disorders [pNCDs]) are described with formal cognitive testing (neurocognitive test battery). Definitions are based on current nomenclature recommendations (Evered et al.) according to DSM-V criteria including a multi-component cognitive test battery comparing baseline and postoperative follow-up testing of patients with cognitive test performance of non-surgical control groups.Cognitive concern and functional ability are described with items from questionnaires, e.g. IQCODE, MMQ, GDS, ADL/IADL and others specific to the respective study design.

Repeated cognitive testing with a battery of computerized neuropsychological tests (Cambridge Neuropsychological Test Automated Battery [CANTAB®]) and non computerized (paper based)tests (e.g. trailmaking test, Grooved pegboard test, Stroop color word interference test, animal naming test, etc.) are performed at preoperative baseline, after 5-7 days and at three months follow up, 1 year, 2 years and 5 years follow-up according to the study design of the registered studies.

Different calculation methods will be applied to the cognitive test data, primarily the dichotomousapproach established by Rasmussen et al. in the International Study on postoperative cognitive deficits (ISPOCD). This calculation method defines POCD as a reliable change in pre- and postoperative cognitive performance (difference scores) of each individual in the surgical patients cohort as compared to the changes in a non-surgical control group (reliable change index in either a composite score including cognitive test parameters from all tests in the cognitive test battery or in at least two of the chosen cognitive test parameters). Additional calculation methods like "g-factor", "GCP" and arbitrary definitions e.g. "20.20- rule" will be used for detailed methodologic evaluation.

In two subprojects we plan to describe domain-specific changes in formal cognitive testing over the registered surgical cohorts.

Subproject 1-Analyses will be performed in joint evaluation with Monument Therapeutics (Spin off Cambridge Cognition). The analyses aim to :

  • Describe cognitive change based on raw cognitive data from the applied cognitive test battery (computerized tests with CANTAB eclipse, CANTAB research suite, CANTAB connect and non-computerized tests)
  • Identify predisposing factors (e.g. patient characteristics, biomarkers, medications) predictive of cognitive decline following surgery
  • Identify the cognitive domains most sensitive to neuropsychological change following surgery

Subproject 2-Analyses will be performed in joint evaluation with Cambridge Cognition. The analyses aim to :

Facilitate the use of data collected from non-surgical controls as normative material for future studies in the research area.

Who can participate

Healthy volunteers accepted: Yes

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

Study Group

Inclusion criteria

  • Age 18 -100 years
  • Male or female patients undergoing elective surgery expected to last at least 60 min, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany
  • Written informed consent to participate after having been properly instructed

Exclusion criteria

  • Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
  • Accommodation in an institution due to an official or judicial order
  • Insufficient knowledge of German language
  • Members of the hospital staff
  • Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone
  • Illiteracy
  • Patients who had a history of neurologic deficits (e.g. stroke, history of seizures, etc.)
  • Hearing impairment that severely affects the neuropsychological testing.
  • Visual impairment that severely affects the neuropsychological testing.
  • Participation in other prospective clinical interventional trials

Control Group

Inclusion criteria

  • Age 18 - 100 years
  • Male or female patients (ASA Status I, II+III)
  • No planned surgery during the next 3 months
  • No surgery during the past 6 months before study inclusion
  • Written informed consent to participate after having been properly instructed

Exclusion criteria

  • Insufficient knowledge of German language Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study
  • Neuropsychiatric conditions that severely affect the neuropsychological testing
  • Hearing impairment that severely affects the neuropsychological testing
  • Visual impairment that severely affects the neuropsychological testing

Treatment and study plan

Primary outcomes

  1. Neurocognitive Disorder (NCD)

    Time frame: Up to 1 year

    Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.

  2. Postoperative cognitive dysfunction (POCD)

    Time frame: Up to 1 year

    Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.

Secondary outcomes

  1. Suspected neurocognitive disorder due to MiniCog

    Time frame: Up to 5 years

    The MiniCog is used for cognitive screening. A cut-off value of <3 points is interpreted possible mild / major NCD. The Mini-Cog consists of a sub-test for word memory skills and a clock drawing test.

  2. Suspected dementia from MOCA

    Time frame: Up to 5 years

    The Montreal Cognitive Assessment (MOCA) with cut-offs according to normative age-adjusted values is used as dementia screening. The MOCA consists of 13 items, which are rated on a scale from 0 to 30 points.

  3. Neurocognitive Disorder (NCD)

    Time frame: Up to 5 years

    Mild / major neurocognitive disorder (mild / major NCD) 60months postoperatively.

  4. Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')

    Time frame: Up to 5 years

    The non-computerized neuropsychological trail making test is used as an indicator screening test for relevant cognitive changes after the operation. The cut-off is an increase in TMT-B test performance of> 55 seconds three and / or 12 months after the operation compared to the baseline value.

  5. Findings from outpatient neurocognitive evaluation (memory clinic)

    Time frame: Up to 1 year

    Results from patient neurocognitive assessment in a memory clinic are evaluated.

  6. Neuroimaging

    Time frame: Up to 5 years

    Technique to image the nervous system.

  7. Normative database

    Time frame: Up to 5 years

    Establishment of a norm database for deriving normative data in a cooperation between the Clinial Research Unit Berlin/Institute of Health (BIH), the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK) at Charité Universitätsmedizin Berlin and Cambridge Cognition.

  8. Perioperative cognitive disorders

    Time frame: Up to 5 years

    Perioperative cognitive disorders for different surgical cohorts are evaluated to describe domain-specific changes over time in formal cognitive tests. These analyzes are carried out in a joint evaluation with Monument Therapeutics as part of a cooperation agreement

  9. Computerized cognitive data

    Time frame: Up to 5 years

    Computerized cognitive data from CANTAB-research suite, CANTAB eclipse and CANTAB connect

  10. Paper-based, non-computerized, cognitive test data

    Time frame: Up to 5 years

    Paper-based, non-computerized, cognitive test data are data from such as IQ equivalent (e.g. MWT-A), MMSE, MOCA, MMQ, Mini-Cog, etc.

  11. Socio-economic Information 1

    Time frame: Up to 5 years

    Soci-economic information is collected by FIMA

  12. Socio-economic Information 2

    Time frame: Up to 5 years

    Soci-economic information is collected by a questionnaire according to Nikolaus 1. Subscale

  13. Comorbidities

    Time frame: Up to 5 years

    Comorbidities are new diagnoses from hospital records.

  14. Charlson comorbidity index

    Time frame: Up to 5 years

    Comorbidity scores

  15. Lifestyle Risks 1

    Time frame: Up to 5 years

    Consumption of alcohol per week.

  16. Lifestyle Risks 2

    Time frame: Up to 5 years

    Consumption of tobacco and nicotine is measured by Fagerström Test for Cigarette Dependence (FTCD). Questionnaire scored 0-10 points with Total Score equal to the sum of all points

  17. Level of education

    Time frame: Up to 5 years

    Level of education is measured by ISCED

  18. Incidence of postoperative delirium

    Time frame: Up to 5 years

    Incidence of postoperative delirium is measured by DDS, DSM-V, CAM/CAM-ICU, NuDESC and Chart review

  19. Duration of postoperative delirium

    Time frame: Up to 5 years

    The Duration of postoperative Delirium is measured in days

  20. Severity of postoperative delirium 1

    Time frame: Up to 5 years

    Severity of delirium 1 is measured by Delirium Detection Score (DDS). The DDS is composed of eight criteria (orientation, hallucination, agitation, anxiety, seizures, tremor, paroxysmal sweating, and altered sleep- wake rhythm). Each item is cored 0,1,4, or 7 points for a possible total score of 0 to 56). Positive if >7.

  21. Severity of postoperative delirium 2

    Time frame: Up to 5 years

    Severity of delirium 2 is measured by Confusion assessment method-short (CAM-S). This is a CAM-based scoring system for delirium severity. The CAM-S uses the same items as the original CAM and rates each symptom 0 for absent, 1 for mild, or 2 for marked; acute onset of fluctuation receives 0 (absent) or 1 (present) (scored 0-10, higher worse).

  22. Severity of postoperative delirium 3

    Time frame: Up to 5 years

    Severity of delirium 3 is measured by DSR-R-98. DRS-R-98 is 16 items clinician rated scale. Total Item: 16 = 3 (for diagnosis) + 13 (for severity).

  23. Severity of postoperative delirium 4

    Time frame: Up to 5 years

    Severity of delirium 4 is measured by ICDSC. Give a score of "1" to each of the 8 items below if the patient clearly meets the criteria defined in the scoring instructions. Give a score of "0" if there is no manifestation orunable to score. If the patient scores >4, notify the physician. The diagnosis of delirium is made following clinical assessment. assessment.

  24. Severity of postoperative delirium 5

    Time frame: Up to 5 years

    Severity of delirium 5 is measured by Nursing Delirium Screening Scale (Nu-DESC). The Nu-DESC is a scale that evaluates the severity of the 5 delirium characteristics on a scale of 0 (not present) to 2 (severe) and takes only 1-2 min to complete, based on the nurses' observations of the patient's behavior during their shifts.

  25. Length of hospital stay

    Time frame: Up to 5 years

    Participants will be followed for the duration of hospital stay, an expected average of 7 days

  26. Quality of life - relatives

    Time frame: Up to 5 years

    Quality of life is measured by CarerQoL

  27. Quality of life - self 1

    Time frame: Up to 5 years

    Quality of life is measured by EQ-5D.An index calculated from the five EQ-5D (3L and 5L) dimensions by attaching specific weights to each severity level in each dimension.

  28. Quality of life - self 2

    Time frame: Up to 5 years

    Quality of life is measured by WHO-5. WHO-5 is a short and generic global rating scale measuring subjective well-being, the respondent is asked to rate how well each of the 5 statements applies to him or her when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The raw score ranges from 0 (absence of well-being) to 25 (maximal well-being). Scores are then converted to a percentage scale from 0 (absent) to 100 (maximal). Higher scores represent greater psychological well-being.

  29. Functional impairment (IADL) 1

    Time frame: Up to 5 years

    Instrumental Activities of Daily Living (IADLs) < 8

  30. Functional impairment (ADL) 2

    Time frame: Up to 5 years

    Activities of Daily Living (ADLs) < 100

  31. Depression 1

    Time frame: Up to 5 years

    Depression 1 is measured by PHQ-8

  32. Depression 2

    Time frame: Up to 5 years

    Depression 2 is measured by GDS

  33. Anxiety scales

    Time frame: Up to 5 years

    Anxiety is measured by GAD-7

  34. Pain

    Time frame: Up to 5 years

    Pain is measured by different scales, e.g. Numeric Rating Scale

  35. Depth of sedation

    Time frame: Up to 5 years

    The sedation is emasured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.

  36. Sedation

    Time frame: Up to 5 years

    Sedation is measured by the Richmond Agitation Sedation Scale

  37. Type of operation

    Time frame: Up to 5 years

    Type of operation is measured by OPS-Code.

  38. Type of anesthesia

    Time frame: Up to 5 years

    There are four main categories of anesthesia used during surgery and other procedures: general anesthesia, regional anesthesia, sedation (sometimes called "monitored anesthesia care"), and local anesthesia.

  39. Type of concomitant medication

    Time frame: Up to 5 years

    The medication administered during the hospital stay is documented.

  40. Anticholinergic Load

    Time frame: Up to 5 years

    Measured by anticholinergic drug scale

  41. Frailty

    Time frame: Up to 5 years

    Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.

  42. Number of participants with changes in laboratory values 1

    Time frame: Up to 5 years

    Laboratory results in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) count and inflammatory markers from blood samples.

  43. Number of participants with changes in laboratory values 2

    Time frame: Up to 5 years

    Laboratory results in the hospital from serum samples

  44. Number of participants with changes in laboratory values 3

    Time frame: Up to 5 years

    Laboratory results in the hospital from urine samples

  45. Number of participants with changes in laboratory values 4

    Time frame: Up to 5 years

    Laboratory results in the hospital from stool samples

  46. Perioperative Electroencephalography

    Time frame: During hospital stay an expected avarage of 7 days

    Electroencephalography (EEG)- Mapping with electrodes.

  47. Nutritional status 1

    Time frame: Up to five years

    Nutritional status 1 is measured by calf circumference

  48. Nutritional status 2

    Time frame: Up to five years

    Nutritional status 2 is measured by arm circumference

  49. Nutritional status 3

    Time frame: Up to five years

    Nutritional status 3 is measured by changes in weight

  50. Nutritional status 4

    Time frame: Up to five years

    Nutritional status 4 is measured by changes in body mass index

  51. Nutritional status 5

    Time frame: Up to five years

    Nutritional status 5 is measured by questions regarding microbiome

  52. Nutritional status 6

    Time frame: Up to five years

    Nutritional status 6 is measured by Medi-Score

  53. Nutritional status 7

    Time frame: Up to five years

    Nutritional status 7 is measured by MNA-SF

  54. Nutritional status 8

    Time frame: Up to five years

    Nutritional status 8 is measured by Sarcopenia, which is identified by criterion 1: low muscle strength, criterion 2: low muscle quantity and criterion 3: low physical performance. Probable sarcopenia is identified by Criterion 1. Diagnosis is confirmed by additional documentation of Criterion 2.

    If Criteria 1, 2 and 3 are all met, sarcopenia is considered severe.

  55. Inhospital diet

    Time frame: Up to five years

    Inhospital diet is measured by patient record.

  56. Eating habits

    Time frame: Up to five years

    Eating habits are measured by patient survey.

Other outcomes

  1. Demographics

    Time frame: Up to 5 years

    Demographics are measured by demographic data.

  2. Neurological diseases

    Time frame: Up to 5 years

    Neurological diseases are taken from the hospital record

  3. Waist circumference

    Time frame: Up to 5 years

    Waist circumference is measured in cm.

  4. Hip circumfernece

    Time frame: Up to 5 years

    Hip circumference is measured in cm.

  5. Obesitas

    Time frame: Up to 5 years

    Obesitas is measured by body mass index.

  6. Metamemory Questionnaire (MMQ) contentment scale

    Time frame: At Baseline

    Metamemory Questionnaire (MMQ) contentment scale is a participant-reported measure of memory satisfaction, ability, and strategy use..

  7. Presurgical Cognitive Impairment (PreCI)

    Time frame: At Baseline

    Presurgical cognitive impairment is determined as cognitive performance of a test battery.

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Spies, MD, Prof.

CONTACT

[email protected]

+49 30 450 5510 01

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin

Important dates

Study start
2009
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2016
Registry last updated
Nov 26, 2025

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

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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.

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