Postoperative Cognitive Deficit (POCD)NCT03540433
International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
An observational study of Postoperative Cognitive Deficit (POCD) and Neurocognitive Disorders, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial summary
The purpose of this international, multi-centre observational study is to describe perioperative cognitive changes (pre-existing neurocognitive disorder [NCD], postoperative delirium [POD] and Postoperative Cognitive Dysfunction [POCD]) up to five years after elective surgery in a mixed cohort. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Deficit (POCD), Neurocognitive Disorders
- How many people
- 173 participants
- Where
- 3 sitesGermany
- Study dates
- 8 Jun 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Surgical patients aged ≥70 years
Who may be able to join
- Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
- Aged ≥ 70 years
- Informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Arbeitsbereich Physikalische Medizin
Berlin, 10117
Internistische Hausarztpraxis
Berlin, 12163
Department of Anesthesiology and Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353
About this study
Official title: Evaluation of POCD-Census Prospective, International Observation Study
The purpose of this international, multi-centre observational study is to describe perioperative cognitive changes (pre-existing neurocognitive disorder [NCD], postoperative delirium [POD] and Postoperative Cognitive Dysfunction [POCD]) up to five years after elective surgery in a mixed cohort. Measurements and definitions of cognitive outcomes will be based on current consensus and used for further harmonization in future clinical studies on perioperative cognitive trajectories. This is a feasibility approach to identify an effective screening procedure and estimate loss to follow up rates for the planning of future intervention studies. Data from this trial may also serve to facilitate and implement time effective cognitive screening and risk stratification concerning postoperative cognitive decline in the anaesthesiological preoperative assessment.
Read the 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.
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Surgical patients aged ≥70 years | |
| Control group | Healthy subjects, aged ≥70 years, American Society of Anesthesiologists (ASA) I+II+III, no surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative cognitive dysfunction (POCD)
Neuropsychological testing
Measured: Up to 1 year
Secondary outcomes (61)
Incidence of postoperative cognitive dysfunction (POCD)
Neuropsychological testing
Measured: Up to 5 years
Positive cognitive screening
Short neuropsychological testing
Measured: Up to 5 years
Mild Neurocognitive Disorder
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
Measured: Up to five years
Major Neurocognitive Disorder
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
Measured: Up to five years
Cerobrospinal fluid biomarker for diagnosing dementia
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)).
Measured: Up to five years
Blood biomarker for diagnosing dementia
Patients consented on blood sampling receive biomarker analysis from blood (Apolipoprotein E).
Measured: Up to five years
Findings of memory consultation session
Measured: Up to five years
Comorbidities
Comorbidities will be quantified by use of Charlson Comorbidity index
Measured: Up to five years
Nutritional status
Changes in the nutritional status after elective surgery are measured by a questionnaire.
Measured: Up to five years
Malnutrition 1
Malnutrition is measured by the Body mass index
Measured: Up to five years
Malnutrition 2
Malnutrition is measured by weight
Measured: Up to five years
Malnutrition 3
Malnutrition is measured by weight
Measured: Up to five years
Dental health
The dental status is determined by tooth doctors
Measured: Up to five years
Sarcopenia
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.
Measured: Up to five years
Calf circumference
Calf circumference is measured in a standardized position and documented in centimeter.
Measured: Up to five years
Arm circumference
Arm circumference is measured in a standardized position and documented in centimeter.
Measured: Up to five years
Adherence to Mediterranean diet (MD)
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.
Measured: Up to five years
Nutrition in the hospital
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Measured: Up to five years
Physical activity
Physical activity is evaluated by interviewing the Patient.
Measured: At the beginning of the observation
Surgical risk
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.
Measured: Participants will be followed up during surgery, an estimated duration of 1 hour
Anaesthesiological Risk 1
Anaesthesiological risk will be described by American Society of Anesthesiologists Classification (ASA Class)
Measured: At the beginning of the observation
Anaesthesiological Risk 2
Anaesthesiological risk will be measured by length of anesthesia
Measured: Participants will be followed up during surgery, an estimated duration of 1 hour
Anaesthesiological Risk 3
Anaesthesiological risk will be measured by type of anaesthesia
Measured: Participants will be followed up during surgery, an estimated duration of 1 hour
Intraoperative depth of anaesthesia
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.
Measured: Participants will be followed up during surgery, an estimated duration of 1 hour
Depth of sedation on the Intensive Care Unit
Sedation is measured by Richmond Agitation Sedation Scale.
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Sedation on the peripheral ward
Sedation is measured by Richmond Agitation Sedation Scale.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Agitation on the peripheral ward
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Incidence of postoperative delirium
Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), CAM/CAM-ICU, Nu-DESC and Chart Review.
Measured: Up to 5 days
Severity of postoperative delirium
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).
Measured: Up to 5 days
Duration of Delirium
Duration of postoperative delirium, defined according to medical evaluation, measured in days
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Pain scale for patients able of pain self-assessment
Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V).
Measured: Up to hospital discharge, an expected average of 5 days
Pain scales for patients unable of pain self-assessment
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.
Measured: Up to hospital discharge, an expected average of 5 days
Intensive care unit length of stay
Intensive care unit length of stay describes every day spent in an ICU bed.
Measured: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
Hospital length of stay
Hospital length of stay describes every day spent in an hospital.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Perioperative Anxiety
Perioperative anxiety will be measured with APAIS preoperatively and the Faces Anxiety Scale (FAS) and during hospital stay.
Measured: Up to 5 days
Perception of stress
Stress is measured by Perceived Stress Questionnaire 20
Measured: Up to 5 days
Stress level
Stress level is measured by stress thermometer
Measured: Up to 5 days
Generalized anxiety
Anxiety will be measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Measured: Up to 5 days
Depression
Depression is measured by PHQ-8. Scores represent:0-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 16-20 = severe depression
Measured: Up to 5 years
Quality of sleep
Quality of sleep is measured by the Insomnia Severity Index.
Measured: Up to 5 years
Routine laboratory
Measured: Up to hospital discharge, an expected average of 7 days
Organ dysfunctions
Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications
Measured: Up to hospital discharge, an expected average of 7 days
Subjective/By proxy assessment of cognitive impairment
Measured: Up to five years
Medication
Prescribed regular drug intake from baseline at all follow ups including perioperative application of drugs, infusions and transfusions will be evaluated.
Measured: Up to 5 years
Quality of life
Quality of life will be measured with the EQ-5D-5L
Measured: Up to 5 years
Level of dependency
Level of dependency will be measured with with ADL/IADL, single items concerning patients' living situation and the BSSS-17 (Berlin Social Support Scales).
Measured: Up to 5 years
Plausibility check variables
Variables affecting performance of cognitive testings
Measured: Up to 5 years
Re-admission
Hospital readmission is an episode when a patient who had been discharged from a hospital is admitted again within a specified time interval.
Measured: Up to 5 years
Revison surgery
Surgery performed to replace or compensate for a failed implant or to correct undesirable sequelae of previous surgery.
Measured: Up to 5 years
Outpatient treatment
Treatment outside of the hospital in an associated facility for diagnosis or treatment.
Measured: Up to 5 years
Mortality
The number of deaths in a given period.
Measured: Up to 5 years
Dementia
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).
Measured: Up to 5 years
Motivational incongruence
The incongruence questionnaire (Der Inkongruenzfragebogen)
Measured: Up to five years
Leisure behavior
Questionnaire on frequency of cognitively stimulating leisure activities
Measured: Up to five years
Demographic variables
Measured: Up to five years
Living conditions
Measured: Up to five years
Postoperative electroencephalography (EEG) spectral analysis with band power
Spectral analysis with band power are measured by EEG at third postoperative day and delirium dependent until postoperative day 7.
Measured: Up to seven days
Evaluation of pain
Pain is measured with dolosys paintracker
Measured: Up to three months
Loneliness
Loneliness is measured with the UCLA-Loneliness-Scale (3 items)
Measured: Up to five years
Social support
Social support is measured with the Berliner Social-Support Skalen BSSS-17
Measured: Up to five years
Living situation
Living situation is measured with te question: How do you live?
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start8 Jun 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive Deficit (POCD)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540433
- Sponsor's protocol ID
- PCI
- Status last verified
- Feb 2025
- First submitted
- 17 May 2018
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of POCD-Census Prospective, International Observation Study
- ClinicalTrials.gov ID
- NCT03540433
- Acronym / sponsor ID
- PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this international, multi-centre observational study is to describe perioperative cognitive changes (pre-existing neurocognitive disorder [NCD], postoperative delirium [POD] and Postoperative Cognitive Dysfunction [POCD]) up to five years after elective surgery in a mixed cohort. Measurements and definitions of cognitive outcomes will be based on current consensus and used for further harmonization in future clinical studies on perioperative cognitive trajectories. This is a feasibility approach to identify an effective screening procedure and estimate loss to follow up rates for the planning of future intervention studies. Data from this trial may also serve to facilitate and implement time effective cognitive screening and risk stratification concerning postoperative cognitive decline in the anaesthesiological preoperative assessment.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Surgical patients aged ≥70 years |
| Control group | – | –Healthy subjects, aged ≥70 years, American Society of Anesthesiologists (ASA) I+II+III, no surgery |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Surgical patients aged ≥70 years
Key inclusion criteria (3 listed)
- Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
- Aged ≥ 70 years
- Informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative cognitive dysfunction (POCD)
Time frame: Up to 1 year
Neuropsychological testing
61 secondary outcomes
Incidence of postoperative cognitive dysfunction (POCD)
Time frame: Up to 5 years
Positive cognitive screening
Time frame: Up to 5 years
Mild Neurocognitive Disorder
Time frame: Up to five years
Major Neurocognitive Disorder
Time frame: Up to five years
Cerobrospinal fluid biomarker for diagnosing dementia
Time frame: Up to five years
Blood biomarker for diagnosing dementia
Time frame: Up to five years
Findings of memory consultation session
Time frame: Up to five years
Comorbidities
Time frame: Up to five years
Nutritional status
Time frame: Up to five years
Malnutrition 1
Time frame: Up to five years
Malnutrition 2
Time frame: Up to five years
Malnutrition 3
Time frame: Up to five years
Dental health
Time frame: Up to five years
Sarcopenia
Time frame: Up to five years
Calf circumference
Time frame: Up to five years
Arm circumference
Time frame: Up to five years
Adherence to Mediterranean diet (MD)
Time frame: Up to five years
Nutrition in the hospital
Time frame: Up to five years
Physical activity
Time frame: At the beginning of the observation
Surgical risk
Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour
Anaesthesiological Risk 1
Time frame: At the beginning of the observation
Anaesthesiological Risk 2
Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour
Anaesthesiological Risk 3
Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour
Intraoperative depth of anaesthesia
Time frame: Participants will be followed up during surgery, an estimated duration of 1 hour
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
Sedation on the peripheral ward
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Agitation on the peripheral ward
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Incidence of postoperative delirium
Time frame: Up to 5 days
Severity of postoperative delirium
Time frame: Up to 5 days
Duration of Delirium
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Pain scale for patients able of pain self-assessment
Time frame: Up to hospital discharge, an expected average of 5 days
Pain scales for patients unable of pain self-assessment
Time frame: Up to hospital discharge, an expected average of 5 days
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
Hospital length of stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Perioperative Anxiety
Time frame: Up to 5 days
Perception of stress
Time frame: Up to 5 days
Stress level
Time frame: Up to 5 days
Generalized anxiety
Time frame: Up to 5 days
Depression
Time frame: Up to 5 years
Quality of sleep
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Cognitive Deficit (POCD) and Neurocognitive Disorders, run by Charite University, Berlin, Germany at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative cognitive dysfunction (POCD) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025; AzTrials last refreshed its copy on 2 Nov 2026.