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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02832193
• Other study ID #: POCD-Registry
• Status: Recruiting
• Start date: March 2009
• Est. completion date: December 2027

Study information

• Verified date: May 2023
• Source: Charite University, Berlin, Germany
• Contact: Claudia Spies, MD, Prof.
• Phone: +49 30 450 5510 01
• Email: claudia.spies[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Study Group

Inclusion Criteria:

• Age 18 -100 years

• Male or female patients undergoing elective surgery expected to last at least 60 min, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, Berlin, Germany

• Written informed consent to participate after having been properly instructed

Exclusion Criteria:

• Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study

• Accommodation in an institution due to an official or judicial order

• Insufficient knowledge of German language

• Members of the hospital staff

• Homelessness or other conditions that disable reachability for postoperative assessment by post or telephone

• Illiteracy

• Patients who had a history of neurologic deficits (e.g. stroke, history of seizures, etc.)

• Hearing impairment that severely affects the neuropsychological testing.

• Visual impairment that severely affects the neuropsychological testing.

• Participation in other prospective clinical interventional trials

Control Group

Inclusion Criteria:

• Age 18 - 100 years

• Male or female patients (ASA Status I, II+III)

• No planned surgery during the next 3 months

• No surgery during the past 6 months before study inclusion

• Written informed consent to participate after having been properly instructed

Exclusion Criteria:

• Insufficient knowledge of German language Lacking willingness to take part in the study, or to have relevant study data collected, saved and analyzed for the purpose of the study

• Neuropsychiatric conditions that severely affect the neuropsychological testing

• Hearing impairment that severely affects the neuropsychological testing

• Visual impairment that severely affects the neuropsychological testing

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin	Berlin
Germany	Irmgard Landgraf	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15. — View Citation

Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Demographics are measured by demographic data.	Up to 5 years
Other	Neurological diseases	Neurological diseases are taken from the hospital record	Up to 5 years
Other	Waist circumference	Waist circumference is measured in cm.	Up to 5 years
Other	Hip circumfernece	Hip circumference is measured in cm.	Up to 5 years
Other	Obesitas	Obesitas is measured by body mass index.	Up to 5 years
Other	Metamemory Questionnaire (MMQ) contentment scale	Metamemory Questionnaire (MMQ) contentment scale is a participant-reported measure of memory satisfaction, ability, and strategy use..	At Baseline
Other	Presurgical Cognitive Impairment (PreCI)	Presurgical cognitive impairment is determined as cognitive performance of a test battery.	At Baseline
Primary	Neurocognitive Disorder (NCD)	Mild / major neurocognitive disorder 3 (mild / major NCD 'Postoperative cognitive dysfunction (POCD)') and 12 months (mild / major NCD) postoperatively.	Up to 1 year
Primary	Postoperative cognitive dysfunction (POCD)	Postoperative cognitive dysfunction (POCD) is defined as relevant change in postoperative cognitive performance compared to baseline (preoperative) cognitive performance.	Up to 1 year
Secondary	Suspected neurocognitive disorder due to MiniCog	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.	Up to 5 years
Secondary	Suspected dementia from MOCA	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.	Up to 5 years
Secondary	Neurocognitive Disorder (NCD)	Mild / major neurocognitive disorder (mild / major NCD) 60months postoperatively.	Up to 5 years
Secondary	Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')	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.	Up to 5 years
Secondary	Findings from outpatient neurocognitive evaluation (memory clinic)	Results from patient neurocognitive assessment in a memory clinic are evaluated.	Up to 1 year
Secondary	Neuroimaging	Technique to image the nervous system.	Up to 5 years
Secondary	Normative database	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.	Up to 5 years
Secondary	Perioperative cognitive disorders	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	Up to 5 years
Secondary	Computerized cognitive data	Computerized cognitive data from CANTAB-research suite, CANTAB eclipse and CANTAB connect	Up to 5 years
Secondary	Paper-based, non-computerized, cognitive test data	Paper-based, non-computerized, cognitive test data are data from such as IQ equivalent (e.g. MWT-A), MMSE, MOCA, MMQ, Mini-Cog, etc.	Up to 5 years
Secondary	Socio-economic Information 1	Soci-economic information is collected by FIMA	Up to 5 years
Secondary	Socio-economic Information 2	Soci-economic information is collected by a questionnaire according to Nikolaus 1. Subscale	Up to 5 years
Secondary	Comorbidities	Comorbidities are new diagnoses from hospital records.	Up to 5 years
Secondary	Charlson comorbidity index	Comorbidity scores	Up to 5 years
Secondary	Lifestyle Risks 1	Consumption of alcohol per week.	Up to 5 years
Secondary	Lifestyle Risks 2	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	Up to 5 years
Secondary	Level of education	Level of education is measured by ISCED	Up to 5 years
Secondary	Incidence of postoperative delirium	Incidence of postoperative delirium is measured by DDS, DSM-V, CAM/CAM-ICU, NuDESC and Chart review	Up to 5 years
Secondary	Duration of postoperative delirium	The Duration of postoperative Delirium is measured in days	Up to 5 years
Secondary	Severity of postoperative delirium 1	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.	Up to 5 years
Secondary	Severity of postoperative delirium 2	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).	Up to 5 years
Secondary	Severity of postoperative delirium 3	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).	Up to 5 years
Secondary	Severity of postoperative delirium 4	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.	Up to 5 years
Secondary	Severity of postoperative delirium 5	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.	Up to 5 years
Secondary	Length of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 7 days	Up to 5 years
Secondary	Quality of life - relatives	Quality of life is measured by CarerQoL	Up to 5 years
Secondary	Quality of life - self 1	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.	Up to 5 years
Secondary	Quality of life - self 2	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.	Up to 5 years
Secondary	Functional impairment (IADL) 1	Instrumental Activities of Daily Living (IADLs) < 8	Up to 5 years
Secondary	Functional impairment (ADL) 2	Activities of Daily Living (ADLs) < 100	Up to 5 years
Secondary	Depression 1	Depression 1 is measured by PHQ-8	Up to 5 years
Secondary	Depression 2	Depression 2 is measured by GDS	Up to 5 years
Secondary	Anxiety scales	Anxiety is measured by GAD-7	Up to 5 years
Secondary	Pain	Pain is measured by different scales, e.g. Numeric Rating Scale	Up to 5 years
Secondary	Depth of sedation	The sedation is emasured intraoperatively processed electroencephalogram (EEG) Full-brain EEG recording with surface electrodes, raw EEG analysis measured during the operation.	Up to 5 years
Secondary	Sedation	Sedation is measured by the Richmond Agitation Sedation Scale	Up to 5 years
Secondary	Type of operation	Type of operation is measured by OPS-Code.	Up to 5 years
Secondary	Type of anesthesia	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.	Up to 5 years
Secondary	Type of concomitant medication	The medication administered during the hospital stay is documented.	Up to 5 years
Secondary	Anticholinergic Load	Measured by anticholinergic drug scale	Up to 5 years
Secondary	Frailty	Frailty is measured with a modified frailty score according to Fried´s frailty phenotype assessment.	Up to 5 years
Secondary	Number of participants with changes in laboratory values 1	Laboratory results in the hospital including hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) count and inflammatory markers from blood samples.	Up to 5 years
Secondary	Number of participants with changes in laboratory values 2	Laboratory results in the hospital from serum samples	Up to 5 years
Secondary	Number of participants with changes in laboratory values 3	Laboratory results in the hospital from urine samples	Up to 5 years
Secondary	Number of participants with changes in laboratory values 4	Laboratory results in the hospital from stool samples	Up to 5 years
Secondary	Perioperative Electroencephalography	Electroencephalography (EEG)- Mapping with electrodes.	During hospital stay an expected avarage of 7 days
Secondary	Nutritional status 1	Nutritional status 1 is measured by calf circumference	Up to five years
Secondary	Nutritional status 2	Nutritional status 2 is measured by arm circumference	Up to five years
Secondary	Nutritional status 3	Nutritional status 3 is measured by changes in weight	Up to five years
Secondary	Nutritional status 4	Nutritional status 4 is measured by changes in body mass index	Up to five years
Secondary	Nutritional status 5	Nutritional status 5 is measured by questions regarding microbiome	Up to five years
Secondary	Nutritional status 6	Nutritional status 6 is measured by Medi-Score	Up to five years
Secondary	Nutritional status 7	Nutritional status 7 is measured by MNA-SF	Up to five years
Secondary	Nutritional status 8	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.	Up to five years
Secondary	Inhospital diet	Inhospital diet is measured by patient record.	Up to five years
Secondary	Eating habits	Eating habits are measured by patient survey.	Up to five years