Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin
- Conditions
- Postoperative Cognitive Dysfunction
- Registration Number
- NCT02832193
- Lead Sponsor
- Charite University, Berlin, Germany
- Brief Summary
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.
- Detailed Description
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 :
1. 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)
2. Identify predisposing factors (e.g. patient characteristics, biomarkers, medications) predictive of cognitive decline following surgery
3. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Neurocognitive Disorder (NCD) Up to 1 year Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.
Postoperative cognitive dysfunction (POCD) Up to 1 year Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.
- Secondary Outcome Measures
Name Time Method Charlson comorbidity index Up to 5 years Comorbidity scores
Findings from outpatient neurocognitive evaluation (memory clinic) Up to 1 year Results from patient neurocognitive assessment in a memory clinic are evaluated.
Severity of postoperative delirium 3 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).
Nutritional status 4 Up to five years Nutritional status 4 is measured by changes in body mass index
Lifestyle Risks 1 Up to 5 years Consumption of alcohol per week.
Nutritional status 7 Up to five years Nutritional status 7 is measured by MNA-SF
Severity of postoperative delirium 1 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.
Lifestyle Risks 2 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
Normative database 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.
Perioperative cognitive disorders 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
Computerized cognitive data Up to 5 years Computerized cognitive data from CANTAB-research suite, CANTAB eclipse and CANTAB connect
Paper-based, non-computerized, cognitive test data 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.
Socio-economic Information 1 Up to 5 years Soci-economic information is collected by FIMA
Socio-economic Information 2 Up to 5 years Soci-economic information is collected by a questionnaire according to Nikolaus 1. Subscale
Quality of life - relatives Up to 5 years Quality of life is measured by CarerQoL
Level of education Up to 5 years Level of education is measured by ISCED
Duration of postoperative delirium Up to 5 years The Duration of postoperative Delirium is measured in days
Severity of postoperative delirium 2 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).
Neurocognitive Disorder (NCD) Up to 5 years Mild / major neurocognitive disorder (mild / major NCD) 60months postoperatively.
Neuroimaging Up to 5 years Technique to image the nervous system.
Incidence of postoperative delirium Up to 5 years Incidence of postoperative delirium is measured by DDS, DSM-V, CAM/CAM-ICU, NuDESC and Chart review
Suspected neurocognitive disorder due to MiniCog 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.
Suspected dementia from MOCA 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.
Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD') 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.
Comorbidities Up to 5 years Comorbidities are new diagnoses from hospital records.
Severity of postoperative delirium 4 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.
Severity of postoperative delirium 5 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.
Length of hospital stay Up to 5 years Participants will be followed for the duration of hospital stay, an expected average of 7 days
Quality of life - self 1 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.
Functional impairment (IADL) 1 Up to 5 years Instrumental Activities of Daily Living (IADLs) \< 8
Functional impairment (ADL) 2 Up to 5 years Activities of Daily Living (ADLs) \< 100
Anxiety scales Up to 5 years Anxiety is measured by GAD-7
Sedation Up to 5 years Sedation is measured by the Richmond Agitation Sedation Scale
Type of operation Up to 5 years Type of operation is measured by OPS-Code.
Quality of life - self 2 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.
Depression 1 Up to 5 years Depression 1 is measured by PHQ-8
Depression 2 Up to 5 years Depression 2 is measured by GDS
Pain Up to 5 years Pain is measured by different scales, e.g. Numeric Rating Scale
Depth of sedation 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.
Type of concomitant medication Up to 5 years The medication administered during the hospital stay is documented.
Anticholinergic Load Up to 5 years Measured by anticholinergic drug scale
Type of anesthesia 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.
Nutritional status 2 Up to five years Nutritional status 2 is measured by arm circumference
Frailty Up to 5 years Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.
Nutritional status 1 Up to five years Nutritional status 1 is measured by calf circumference
Number of participants with changes in laboratory values 1 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.
Number of participants with changes in laboratory values 2 Up to 5 years Laboratory results in the hospital from serum samples
Number of participants with changes in laboratory values 3 Up to 5 years Laboratory results in the hospital from urine samples
Number of participants with changes in laboratory values 4 Up to 5 years Laboratory results in the hospital from stool samples
Perioperative Electroencephalography During hospital stay an expected avarage of 7 days Electroencephalography (EEG)- Mapping with electrodes.
Nutritional status 3 Up to five years Nutritional status 3 is measured by changes in weight
Nutritional status 5 Up to five years Nutritional status 5 is measured by questions regarding microbiome
Nutritional status 6 Up to five years Nutritional status 6 is measured by Medi-Score
Eating habits Up to five years Eating habits are measured by patient survey.
Nutritional status 8 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.Inhospital diet Up to five years Inhospital diet is measured by patient record.
Trial Locations
- Locations (2)
Irmgard Landgraf
🇩🇪Berlin, Germany
Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany