Clinical trial NCT02832193: Retrospective Evaluation of POCD Data of Studies From KAI, Charité - Universitätsmedizin Berlin
Official title: Retrospective Evaluation of POCD Data of Studies From the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK) Charité - Universitätsmedizin Berlin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Cognitive Dysfunction
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients undergoing surgery, screened at the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurocognitive Disorder (NCD)
timeFrame: Up to 1 year
measure: Postoperative cognitive dysfunction (POCD)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Suspected neurocognitive disorder due to MiniCog
timeFrame: Up to 5 years
measure: Suspected dementia from MOCA
timeFrame: Up to 5 years
measure: Neurocognitive Disorder (NCD)
timeFrame: Up to 5 years
measure: Suspected postoperative neurocognitive disorder (mild / major NCD 'POCD')
timeFrame: Up to 5 years
measure: Findings from outpatient neurocognitive evaluation (memory clinic)
timeFrame: Up to 1 year
measure: Neuroimaging
timeFrame: Up to 5 years
measure: Normative database
timeFrame: Up to 5 years
measure: Perioperative cognitive disorders
timeFrame: Up to 5 years
measure: Computerized cognitive data
timeFrame: Up to 5 years
measure: Paper-based, non-computerized, cognitive test data
timeFrame: Up to 5 years
measure: Socio-economic Information 1
timeFrame: Up to 5 years
measure: Socio-economic Information 2
timeFrame: Up to 5 years
measure: Comorbidities
timeFrame: Up to 5 years
measure: Charlson comorbidity index
timeFrame: Up to 5 years
measure: Lifestyle Risks 1
timeFrame: Up to 5 years
measure: Lifestyle Risks 2
timeFrame: Up to 5 years
measure: Level of education
timeFrame: Up to 5 years
measure: Incidence of postoperative delirium
timeFrame: Up to 5 years
measure: Duration of postoperative delirium
timeFrame: Up to 5 years
measure: Severity of postoperative delirium 1
timeFrame: Up to 5 years
measure: Severity of postoperative delirium 2
timeFrame: Up to 5 years
measure: Severity of postoperative delirium 3
timeFrame: Up to 5 years
measure: Severity of postoperative delirium 4
timeFrame: Up to 5 years
measure: Severity of postoperative delirium 5
timeFrame: Up to 5 years
measure: Length of hospital stay
timeFrame: Up to 5 years
measure: Quality of life - relatives
timeFrame: Up to 5 years
measure: Quality of life - self 1
timeFrame: Up to 5 years
measure: Quality of life - self 2
timeFrame: Up to 5 years
measure: Functional impairment (IADL) 1
timeFrame: Up to 5 years
measure: Functional impairment (ADL) 2
timeFrame: Up to 5 years
measure: Depression 1
timeFrame: Up to 5 years
measure: Depression 2
timeFrame: Up to 5 years
measure: Anxiety scales
timeFrame: Up to 5 years
measure: Pain
timeFrame: Up to 5 years
measure: Depth of sedation
timeFrame: Up to 5 years
measure: Sedation
timeFrame: Up to 5 years
measure: Type of operation
timeFrame: Up to 5 years
measure: Type of anesthesia
timeFrame: Up to 5 years
measure: Type of concomitant medication
timeFrame: Up to 5 years
measure: Anticholinergic Load
timeFrame: Up to 5 years
measure: Frailty
timeFrame: Up to 5 years
measure: Number of participants with changes in laboratory values 1
timeFrame: Up to 5 years
measure: Number of participants with changes in laboratory values 2
timeFrame: Up to 5 years
measure: Number of participants with changes in laboratory values 3
timeFrame: Up to 5 years
measure: Number of participants with changes in laboratory values 4
timeFrame: Up to 5 years
measure: Perioperative Electroencephalography
timeFrame: During hospital stay an expected avarage of 7 days
measure: Nutritional status 1
timeFrame: Up to five years
measure: Nutritional status 2
timeFrame: Up to five years
measure: Nutritional status 3
timeFrame: Up to five years
measure: Nutritional status 4
timeFrame: Up to five years
measure: Nutritional status 5
timeFrame: Up to five years
measure: Nutritional status 6
timeFrame: Up to five years
measure: Nutritional status 7
timeFrame: Up to five years
measure: Nutritional status 8
timeFrame: Up to five years
measure: Inhospital diet
timeFrame: Up to five years
measure: Eating habits
timeFrame: Up to five years
Other outcomes:
measure: Demographics
timeFrame: Up to 5 years
measure: Neurological diseases
timeFrame: Up to 5 years
measure: Waist circumference
timeFrame: Up to 5 years
measure: Hip circumfernece
timeFrame: Up to 5 years
measure: Obesitas
timeFrame: Up to 5 years
measure: Metamemory Questionnaire (MMQ) contentment scale
timeFrame: At Baseline
measure: Presurgical Cognitive Impairment (PreCI)
timeFrame: At Baseline
Locations:
city: Berlin
country: Germany
facility: Irmgard Landgraf
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine Berlin (CCM, CVK), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
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.
citation: 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.