Clinical trial NCT03540433: International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
Official title: Evaluation of POCD-Census Prospective, International Observation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Deficit (POCD)
Neurocognitive Disorders
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 173
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical patients aged ≥70 years

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of postoperative cognitive dysfunction (POCD)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Incidence of postoperative cognitive dysfunction (POCD)
timeFrame: Up to 5 years
measure: Positive cognitive screening
timeFrame: Up to 5 years
measure: Mild Neurocognitive Disorder
timeFrame: Up to five years
measure: Major Neurocognitive Disorder
timeFrame: Up to five years
measure: Cerobrospinal fluid biomarker for diagnosing dementia
timeFrame: Up to five years
measure: Blood biomarker for diagnosing dementia
timeFrame: Up to five years
measure: Findings of memory consultation session
timeFrame: Up to five years
measure: Comorbidities
timeFrame: Up to five years
measure: Nutritional status
timeFrame: Up to five years
measure: Malnutrition 1
timeFrame: Up to five years
measure: Malnutrition 2
timeFrame: Up to five years
measure: Malnutrition 3
timeFrame: Up to five years
measure: Dental health
timeFrame: Up to five years
measure: Sarcopenia
timeFrame: Up to five years
measure: Calf circumference
timeFrame: Up to five years
measure: Arm circumference
timeFrame: Up to five years
measure: Adherence to Mediterranean diet (MD)
timeFrame: Up to five years
measure: Nutrition in the hospital
timeFrame: Up to five years
measure: Physical activity
timeFrame: At the beginning of the observation
measure: Surgical risk
timeFrame: Participants will be followed up during surgery, an estimated duration of 1 hour
measure: Anaesthesiological Risk 1
timeFrame: At the beginning of the observation
measure: Anaesthesiological Risk 2
timeFrame: Participants will be followed up during surgery, an estimated duration of 1 hour
measure: Anaesthesiological Risk 3
timeFrame: Participants will be followed up during surgery, an estimated duration of 1 hour
measure: Intraoperative depth of anaesthesia
timeFrame: Participants will be followed up during surgery, an estimated duration of 1 hour
measure: Depth of sedation on the Intensive Care Unit
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
measure: Sedation on the peripheral ward
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Agitation on the peripheral ward
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Incidence of postoperative delirium
timeFrame: Up to 5 days
measure: Severity of postoperative delirium
timeFrame: Up to 5 days
measure: Duration of Delirium
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Pain scale for patients able of pain self-assessment
timeFrame: Up to hospital discharge, an expected average of 5 days
measure: Pain scales for patients unable of pain self-assessment
timeFrame: Up to hospital discharge, an expected average of 5 days
measure: Intensive care unit length of stay
timeFrame: Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
measure: Hospital length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Perioperative Anxiety
timeFrame: Up to 5 days
measure: Perception of stress
timeFrame: Up to 5 days
measure: Stress level
timeFrame: Up to 5 days
measure: Generalized anxiety
timeFrame: Up to 5 days
measure: Depression
timeFrame: Up to 5 years
measure: Quality of sleep
timeFrame: Up to 5 years
measure: Routine laboratory
timeFrame: Up to hospital discharge, an expected average of 7 days
measure: Organ dysfunctions
timeFrame: Up to hospital discharge, an expected average of 7 days
measure: Subjective/By proxy assessment of cognitive impairment
timeFrame: Up to five years
measure: Medication
timeFrame: Up to 5 years
measure: Quality of life
timeFrame: Up to 5 years
measure: Level of dependency
timeFrame: Up to 5 years
measure: Plausibility check variables
timeFrame: Up to 5 years
measure: Re-admission
timeFrame: Up to 5 years
measure: Revison surgery
timeFrame: Up to 5 years
measure: Outpatient treatment
timeFrame: Up to 5 years
measure: Mortality
timeFrame: Up to 5 years
measure: Dementia
timeFrame: Up to 5 years
measure: Motivational incongruence
timeFrame: Up to five years
measure: Leisure behavior
timeFrame: Up to five years
measure: Demographic variables
timeFrame: Up to five years
measure: Living conditions
timeFrame: Up to five years
measure: Postoperative electroencephalography (EEG) spectral analysis with band power
timeFrame: Up to seven days
measure: Evaluation of pain
timeFrame: Up to three months
measure: Loneliness
timeFrame: Up to five years
measure: Social support
timeFrame: Up to five years
measure: Living situation
timeFrame: Up to five years
Other outcomes:
measure: Obesity 1
timeFrame: At the beginning of the observation
measure: Obesity 2
timeFrame: At the beginning of the observation
measure: Variables of adjusting
timeFrame: At the beginning of the observation
measure: Frailty
timeFrame: At the beginning of the observation
measure: Cognitive Reserve
timeFrame: At the beginning of the observation
measure: Crystalline Intelligence
timeFrame: At the beginning of the observation
measure: Previous professional activity
timeFrame: At the beginning of the observation
measure: Delusion proneness
timeFrame: At the beginning of the observation
measure: Physical activity
timeFrame: At the beginning of the observation
measure: Pre-operative electroencephalography (EEG) spectral analysis with band power
timeFrame: At the beginning of the observation
measure: Preoperative Cognitive Impairment (PreCI)
timeFrame: At the beginning of the observation
Locations:
city: Berlin
country: Germany
facility: Arbeitsbereich Physikalische Medizin
city: Berlin
country: Germany
facility: Internistische Hausarztpraxis
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin
Study officials:
References: