- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03540433
International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
Evaluation of POCD-Census Prospective, International Observation Study
Study Overview
Status
Detailed Description
This international observational study on perioperative cognitive trajectories (POCD census international/PCI) has been designed as a pilot study to allow a peer reviewed process of four international test centres on measurement of perioperative acute and long-term cognitive outcome. Data from standard clinical treatment of 500 patients age ≥ 70 years scheduled for elective surgery (stratified according to preoperative assessment of frailty and monitored by intraoperative depth of anaesthesia) will be supplemented by guideline conform delirium- analgesia- and sedation screening until day 5 after surgery, I-Pad based neuropsychological testing [Cambridge Neuropsychological Test Automated Battery - CANTAB connect] pre-operatively, 3 months, 1- 2- and 5 years after surgery, a paper-based verbal fluency test (animal naming test from Addenbrooke's Cognitive Examination Revised (ACE-R)), a paper based test on executive function (Trailmaking Test), cognitive screening tests (Montreal Cognitive Assessment (MOCA) and Mini-Cog), and concomitant questionnaires to assess functional status, self- and by proxy rating of cognitive performance, psychological factors (depression, perioperative anxiety, stress, resilience and coping), social support, perioperative anxiety, stress, resilience and coping, as well as risk consumption of alcohol and tobacco.
A non-surgical control group of 100 study participants who are not scheduled for surgery will be followed up at the same time points as the surgical cohort for scaling of cognitive data and definition of cut off values to define significant cognitive decline.
Secondary outcome measures of this trial comprise levels and changes in molecular biomarkers involved in Alzheimer's dementia etiology sampled from spinal fluid on induction of spinal anaesthesia and sampled from blood in all patients.
Retrospective comparison collective (01/01/2017 to 01/01/2022):
A group of around 8000 surgical patients aged 65 and older at the Charité will be examined as control group. This control group is required for various questions, especially influencing factors with regard to the postoperative outcome of delirium, and aims to test the predictive ability of clinical routine data with regard to postoperative delirium. As part of the multimodality of this retrospective comparative cohort study, in cooperation with PD. Dr Scheel and in collaboration with Prof. Dr. Finke, cranial MRI scans analyzing routine data from the Institute of Neuroradiology. The subject of the investigation is initially the entire electronic routine data of the control group, including the existing cranial MRI scans.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Berlin, Germany, 10117
- Arbeitsbereich Physikalische Medizin
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Berlin, Germany, 12163
- Internistische Hausarztpraxis
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Berlin, Germany, 13353
- Department of Anesthesiology and Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
- Aged ≥ 70 years
- Informed consent
Exclusion Criteria:
- Manifest dementia
- Lack of willingness to store and disseminate pseudonymized disease data as part of the clinical trial
- Lack of readiness to participate in the follow-up examinations and contact to make an appointment
- Placement in an institute under judicial or official orders (according to German drug Law §40 (1) 4)
- Persons without a permanent residence or other circumstances that call into question the availability by telephone or post for postoperative examination
- Employees of the respective study centers
- illiteracy
- Patients with a neuropsychiatric condition that limits the performance of neurocognitive testing
- Patients with hearing and / or vision problems that limit the performance of neuro-cognitive testing
- Simultaneous participation in a prospective clinical intervention study (apart from the desired parallel participation in the anaesthesiological study Praep-Go, EA1/225/19)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Study group
Surgical patients aged ≥70 years
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Control group
Healthy subjects, aged ≥70 years, American Society of Anesthesiologists (ASA) I+II+III, no surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postoperative cognitive dysfunction (POCD)
Time Frame: Up to 1 year
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Neuropsychological testing
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Up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postoperative cognitive dysfunction (POCD)
Time Frame: Up to 5 years
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Neuropsychological testing
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Up to 5 years
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Positive cognitive screening
Time Frame: Up to 5 years
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Short neuropsychological testing
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Up to 5 years
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Mild Neurocognitive Disorder
Time Frame: Up to five years
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Definition according to DSM-V as proposed in Evered L et al.
Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery.
Br J Anaesth, Anesthesiology, Can J Anesth, Anesth Analg, J Alz Dis, acta scandinavica anaesthesiologica (Joint Publication) 2017; Accepted, In Press.
We will use an I-pad based neuropsychological test battery (CANTAB connect), and cognitive screening instruments (MOCA, Mini-Cog™ and Animal naming test on verbal fluency from ACE-R) for assessment of cognitive function, MMQ and IQ-code for self- or by proxy reported cognitive concern and ADL/IADL for assessment of functional status.
Mild/major Neurocognitive Disorder measured at baseline (pre-existing NCD) 3 months and 1 year (with specifier 'POCD'), 2- and 5 years after surgery
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Up to five years
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Major Neurocognitive Disorder
Time Frame: Up to five years
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Definition according to DSM-V as proposed in Evered L et al.
Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery.
Br J Anaesth, Anesthesiology, Can J Anesth, Anesth Analg, J Alz Dis, acta scandinavica anaesthesiologica (Joint Publication) 2017; Accepted, In Press.
We will use an I-pad based neuropsychological test battery (CANTAB connect), and cognitive screening instruments (MOCA, Mini-Cog™ and Animal naming test on verbal fluency from ACE-R) for assessment of cognitive function, MMQ and IQ-code for self- or by proxy reported cognitive concern and ADL/IADL for assessment of functional status.
Mild/major Neurocognitive Disorder measured at baseline (pre-existing NCD) 3 months and 1 year (with specifier 'POCD'), 2- and 5 years after surgery
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Up to five years
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Cerobrospinal fluid biomarker for diagnosing dementia
Time Frame: Up to five years
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Patients for spinal anesthesia who consented on lumbar puncture receive biomarkers analysis from spinal fluid (beta Amyloid 1-40, beta-Amyloid 1-42, beta-Amyloid Ratio (42/40*10), phospho-TAU, Protein 14-3-3, PRPSc, TAU (Gesamt-Tau)).
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Up to five years
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Blood biomarker for diagnosing dementia
Time Frame: Up to five years
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Patients consented on blood sampling receive biomarker analysis from blood (Apolipoprotein E).
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Up to five years
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Findings of memory consultation session
Time Frame: Up to five years
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Up to five years
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Comorbidities
Time Frame: Up to five years
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Comorbidities will be quantified by use of Charlson Comorbidity index
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Up to five years
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Malnutrition 3
Time Frame: Up to five years
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Malnutrition is measured by weight
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Up to five years
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Dental health
Time Frame: Up to five years
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The dental status is determined by tooth doctors
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Up to five years
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Sarcopenia
Time Frame: Up to five years
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The composite outcome measure "Sarcopenia" is defined by the following three criteria: 1) low muscle strength (hand grip strength), 2) low muscle quantity (calf circumference and 3) low physical performance (gait speed).
Criterion (1) identifies probable sarcopenia, additional documentation of criterion (2) confirms sarcopenia diagnosis, and if all criteria (1), (2) and (3) are met, sarcopenia is considered severe.
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Up to five years
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Calf circumference
Time Frame: Up to five years
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Calf circumference is measured in a standardized position and documented in centimeter.
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Up to five years
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Arm circumference
Time Frame: Up to five years
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Arm circumference is measured in a standardized position and documented in centimeter.
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Up to five years
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Adherence to Mediterranean diet (MD)
Time Frame: Up to five years
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Adherence to Mediterranean diet (MD) is measured with a German Mediscore, could range from 0 to 9, with higher scores (6-9) indicating greater MD adherence.
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Up to five years
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Nutrition in the hospital
Time Frame: Up to five years
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Up to five years
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Physical activity
Time Frame: At the beginning of the observation
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Physical activity is evaluated by interviewing the Patient.
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At the beginning of the observation
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Surgical risk
Time Frame: Participants will be followed up during surgery, an estimated duration of 1 hour
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Surgical risk will be described by type and length of surgery and perioperative cardiac risk estimation as described in Anästh Intensivmed 2017; 58:349-364.
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Participants will be followed up during surgery, an estimated duration of 1 hour
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Anaesthesiological Risk 1
Time Frame: At the beginning of the observation
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Anaesthesiological risk will be described by American Society of Anesthesiologists Classification (ASA Class)
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At the beginning of the observation
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Anaesthesiological Risk 2
Time Frame: Participants will be followed up during surgery, an estimated duration of 1 hour
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Anaesthesiological risk will be measured by length of anesthesia
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Participants will be followed up during surgery, an estimated duration of 1 hour
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Anaesthesiological Risk 3
Time Frame: Participants will be followed up during surgery, an estimated duration of 1 hour
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Anaesthesiological risk will be measured by type of anaesthesia
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Participants will be followed up during surgery, an estimated duration of 1 hour
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Intraoperative depth of anaesthesia
Time Frame: Participants will be followed up during surgery, an estimated duration of 1 hour
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Intraoperative depth of sedation will be monitored with changes in the pattern and power spectrum of EEG-raw data measured with the Masimo SedLine® brain function monitoring for Root®, Narcotrend®, BIS™ and additionally quantified by indices [e.g.
PSI or BIS-index] and burst suppression ratio.
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Participants will be followed up during surgery, an estimated duration of 1 hour
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Depth of sedation on the Intensive Care Unit
Time Frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
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Sedation is measured by Richmond Agitation Sedation Scale.
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Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
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Sedation on the peripheral ward
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Sedation is measured by Richmond Agitation Sedation Scale.
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Agitation on the peripheral ward
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Agitation describes a clinical state in which the patient may be impulsive and attempt to get out of bed, to wander, and to fall (which may lead to further injury or death) and attempt to remove IV lines, tubes, or catheters.
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Incidence of postoperative delirium
Time Frame: Up to 5 days
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Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), CAM/CAM-ICU, Nu-DESC and Chart Review.
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Up to 5 days
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Severity of postoperative delirium
Time Frame: Up to 5 days
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Postoperative delirium rate, defined according to Confusion assessment method - severity(CAM-S); Delirium Rating Scale Revised (DSR-R-98), Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC).
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Up to 5 days
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Pain scale for patients able of pain self-assessment
Time Frame: Up to hospital discharge, an expected average of 5 days
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Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V).
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Up to hospital discharge, an expected average of 5 days
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Pain scales for patients unable of pain self-assessment
Time Frame: Up to hospital discharge, an expected average of 5 days
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For patients unable of pain self-assessment (e.g.
ventilated patients, patients in delirious state or patients with stroke affecting language skills) observer-rated pain scales will be applied: Behavioural Pain Scale (BPS for ventilated) and BPS-NI (for non-ventilated) patients, Critical-Care Pain Observation Tool (CPOT) during hospital stay.
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Up to hospital discharge, an expected average of 5 days
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Intensive care unit length of stay
Time Frame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
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Intensive care unit length of stay describes every day spent in an ICU bed.
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Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
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Hospital length of stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Hospital length of stay describes every day spent in an hospital.
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Perioperative Anxiety
Time Frame: Up to 5 days
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Perioperative anxiety will be measured with APAIS preoperatively and the Faces Anxiety Scale (FAS) and during hospital stay.
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Up to 5 days
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Perception of stress
Time Frame: Up to 5 days
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Stress is measured by Perceived Stress Questionnaire 20
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Up to 5 days
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Stress level
Time Frame: Up to 5 days
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Stress level is measured by stress thermometer
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Up to 5 days
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Generalized anxiety
Time Frame: Up to 5 days
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Anxiety will be measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
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Up to 5 days
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Depression
Time Frame: Up to 5 years
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Depression is measured by PHQ-8.
Scores represent:0-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 16-20 = severe depression
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Up to 5 years
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Quality of sleep
Time Frame: Up to 5 years
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Quality of sleep is measured by the Insomnia Severity Index.
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Up to 5 years
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Routine laboratory
Time Frame: Up to hospital discharge, an expected average of 7 days
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Up to hospital discharge, an expected average of 7 days
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Organ dysfunctions
Time Frame: Up to hospital discharge, an expected average of 7 days
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Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications
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Up to hospital discharge, an expected average of 7 days
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Subjective/By proxy assessment of cognitive impairment
Time Frame: Up to five years
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Up to five years
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Medication
Time Frame: Up to 5 years
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Prescribed regular drug intake from baseline at all follow ups including perioperative application of drugs, infusions and transfusions will be evaluated.
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Up to 5 years
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Quality of life
Time Frame: Up to 5 years
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Quality of life will be measured with the EQ-5D-5L
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Up to 5 years
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Level of dependency
Time Frame: Up to 5 years
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Level of dependency will be measured with with ADL/IADL, single items concerning patients' living situation and the BSSS-17 (Berlin Social Support Scales).
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Up to 5 years
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Plausibility check variables
Time Frame: Up to 5 years
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Variables affecting performance of cognitive testings
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Up to 5 years
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Re-admission
Time Frame: Up to 5 years
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Hospital readmission is an episode when a patient who had been discharged from a hospital is admitted again within a specified time interval.
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Up to 5 years
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Revison surgery
Time Frame: Up to 5 years
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Surgery performed to replace or compensate for a failed implant or to correct undesirable sequelae of previous surgery.
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Up to 5 years
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Outpatient treatment
Time Frame: Up to 5 years
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Treatment outside of the hospital in an associated facility for diagnosis or treatment.
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Up to 5 years
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Mortality
Time Frame: Up to 5 years
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The number of deaths in a given period.
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Up to 5 years
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Dementia
Time Frame: Up to 5 years
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Dementia reported as clinical diagnosis based on DSM-5 criteria for major NCD either through neuropsychological evaluation at a memory clinic or as a research diagnosis based on neuropsychological test values (CANTAB/MOCA), cognitive concern (MMQ/IQCODE) and functionality (ADL/IADL).
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Up to 5 years
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Motivational incongruence
Time Frame: Up to five years
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The incongruence questionnaire (Der Inkongruenzfragebogen)
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Up to five years
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Leisure behavior
Time Frame: Up to five years
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Questionnaire on frequency of cognitively stimulating leisure activities
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Up to five years
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Demographic variables
Time Frame: Up to five years
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Up to five years
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Living conditions
Time Frame: Up to five years
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Up to five years
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Postoperative electroencephalography (EEG) spectral analysis with band power
Time Frame: Up to seven days
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Spectral analysis with band power are measured by EEG at third postoperative day and delirium dependent until postoperative day 7.
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Up to seven days
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Evaluation of pain
Time Frame: Up to three months
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Pain is measured with dolosys paintracker
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Up to three months
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Loneliness
Time Frame: Up to five years
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Loneliness is measured with the UCLA-Loneliness-Scale (3 items)
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Up to five years
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Social support
Time Frame: Up to five years
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Social support is measured with the Berliner Social-Support Skalen BSSS-17
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Up to five years
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Living situation
Time Frame: Up to five years
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Living situation is measured with te question: How do you live?
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Up to five years
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Nutritional status
Time Frame: Up to five years
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Changes in the nutritional status after elective surgery are measured by a questionnaire.
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Up to five years
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Malnutrition 1
Time Frame: Up to five years
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Malnutrition is measured by the Body mass index
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Up to five years
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Malnutrition 2
Time Frame: Up to five years
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Malnutrition is measured by weight
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Up to five years
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Duration of Delirium
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Duration of postoperative delirium, defined according to medical evaluation, measured in days
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Obesity 1
Time Frame: At the beginning of the observation
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Obesity is measured by body mass index (BMI)
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At the beginning of the observation
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Obesity 2
Time Frame: At the beginning of the observation
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Obesity is measured by waist to hip ratio
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At the beginning of the observation
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Variables of adjusting
Time Frame: At the beginning of the observation
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Reading / writing weakness, hendedness, native speaker
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At the beginning of the observation
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Frailty
Time Frame: At the beginning of the observation
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Frailty will be measured by Fried's criteria (Physical Frailty Phenotype), Fried et al: Frailty in older adults: evidence for a phenotype.
J.Gerontol.A Biol.Sci.Med.Sci.
2001; 56: M146-M156 and evaluated in a short comprehensive geriatric assessment as decribed by Birkelbach, O. et al.
Warum und wie sollte ich Frailty erfassen?
- ein Ansatz für die Anästhesieambulanz.
Anasthesiol.
Intensivmed.
Notfallmedizin Schmerztherapie 52, 765-776 (2017).
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At the beginning of the observation
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Cognitive Reserve
Time Frame: At the beginning of the observation
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Level of education (years of formal training, last occupation, ISCED-2011 and crystalline intelligence [IQ-variable calculated with NART/MWT-A or other national equivalent ] will be used to evaluate cognitive reserve.
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At the beginning of the observation
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Crystalline Intelligence
Time Frame: At the beginning of the observation
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Mehrfachwahl-Wortschatz-Intelligenztest (MWT-A) and National Adult Reading Test (NART)
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At the beginning of the observation
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Previous professional activity
Time Frame: At the beginning of the observation
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Interview guide employment situation and previous professional activity adapted to Engstler (2017); Classification according to ISCO 08; Workload indices according to Kroll (2011)
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At the beginning of the observation
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Delusion proneness
Time Frame: At the beginning of the observation
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Delusion proneness is measured by Peter's Delusion Inventory
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At the beginning of the observation
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Physical activity
Time Frame: At the beginning of the observation
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History of physical activity less than 30 minutes / day (i.e.
moderate increase in heart rate due to fast walking, cycling or other exercise)
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At the beginning of the observation
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Pre-operative electroencephalography (EEG) spectral analysis with band power
Time Frame: At the beginning of the observation
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Spectral analysis with band power are measured by EEG
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At the beginning of the observation
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Preoperative Cognitive Impairment (PreCI)
Time Frame: At the beginning of the observation
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Preoperative Cognitive Impairment (PreCI) is measured by computerized and paper pencil tests
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At the beginning of the observation
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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