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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03540433
Registration number
NCT03540433
Ethics application status
Date submitted
17/05/2018
Date registered
30/05/2018
Date last updated
8/06/2022
Titles & IDs
Public title
International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
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Scientific title
Evaluation of POCD-Census Prospective, International Observation Study
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Secondary ID [1]
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PCI
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Postoperative Cognitive Deficit (POCD)
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Neurocognitive Disorders
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Mental Health
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Learning disabilities
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Neurological
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Dementias
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Study group - Surgical patients aged =70 years
Control group - Healthy subjects, aged =70 years, American Society of Anesthesiologists (ASA) I+II+III, no surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of postoperative cognitive dysfunction (POCD)
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Assessment method [1]
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Neuropsychological testing
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Timepoint [1]
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Up to 1 year
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Secondary outcome [1]
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Incidence of postoperative cognitive dysfunction (POCD)
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Assessment method [1]
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Neuropsychological testing
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Timepoint [1]
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Up to 5 years
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Secondary outcome [2]
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Positive cognitive screening
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Assessment method [2]
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Short neuropsychological testing
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Mild Neurocognitive Disorder
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Assessment method [3]
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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
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Timepoint [3]
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Up to five years
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Secondary outcome [4]
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Major Neurocognitive Disorder
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Assessment method [4]
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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
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Timepoint [4]
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Up to five years
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Secondary outcome [5]
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Cerobrospinal fluid biomarker for diagnosing dementia
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Assessment method [5]
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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)).
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Timepoint [5]
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Up to five years
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Secondary outcome [6]
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Blood biomarker for diagnosing dementia
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Assessment method [6]
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Patients consented on blood sampling receive biomarker analysis from blood (Apolipoprotein E).
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Timepoint [6]
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Up to five years
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Secondary outcome [7]
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Findings of memory consultation session
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Assessment method [7]
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0
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Timepoint [7]
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Up to five years
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Secondary outcome [8]
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Comorbidities
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Assessment method [8]
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0
Comorbidities will be quantified by use of Charlson Comorbidity index
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Timepoint [8]
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Up to five years
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Secondary outcome [9]
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Malnutrition 1
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Assessment method [9]
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Malnutrition is measured by the Mini Nutritional Assessment - Short Form (MNA®-SF)
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Timepoint [9]
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Up to five years
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Secondary outcome [10]
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Malnutrition 2
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Assessment method [10]
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Malnutrition is measured by the Body mass index
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Timepoint [10]
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Up to five years
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Secondary outcome [11]
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Malnutrition 3
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Assessment method [11]
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Malnutrition is measured by weight
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Timepoint [11]
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Up to five years
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Secondary outcome [12]
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Malnutrition 4
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Assessment method [12]
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Malnutrition is measured by weight
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Timepoint [12]
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Up to five years
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Secondary outcome [13]
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Dental health
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Assessment method [13]
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The dental status is determined by tooth doctors
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Timepoint [13]
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Up to five years
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Secondary outcome [14]
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Sarcopenia
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Assessment method [14]
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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.
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Timepoint [14]
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Up to five years
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Secondary outcome [15]
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Calf circumference
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Assessment method [15]
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Calf circumference is measured in a standardized position and documented in centimeter.
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Timepoint [15]
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Up to five years
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Secondary outcome [16]
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Arm circumference
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Assessment method [16]
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Arm circumference is measured in a standardized position and documented in centimeter.
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Timepoint [16]
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Up to five years
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Secondary outcome [17]
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Adherence to Mediterranean diet (MD)
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Assessment method [17]
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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.
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Timepoint [17]
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Up to five years
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Secondary outcome [18]
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Nutrition in the hospital
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Assessment method [18]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Timepoint [18]
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Up to five years
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Secondary outcome [19]
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Physical activity
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Assessment method [19]
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Physical activity is evaluated by interviewing the Patient.
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Timepoint [19]
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At the beginning of the observation
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Secondary outcome [20]
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Surgical risk
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Assessment method [20]
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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.
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Timepoint [20]
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Participants will be followed up during surgery, an estimated duration of 1 hour
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Secondary outcome [21]
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Anaesthesiological Risk 1
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Assessment method [21]
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Anaesthesiological risk will be described by American Society of Anesthesiologists Classification (ASA Class)
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Timepoint [21]
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At the beginning of the observation
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Secondary outcome [22]
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Anaesthesiological Risk 2
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Assessment method [22]
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Anaesthesiological risk will be measured by length of anesthesia
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Timepoint [22]
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Participants will be followed up during surgery, an estimated duration of 1 hour
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Secondary outcome [23]
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Anaesthesiological Risk 3
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Assessment method [23]
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Anaesthesiological risk will be measured by type of anaesthesia
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Timepoint [23]
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Participants will be followed up during surgery, an estimated duration of 1 hour
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Secondary outcome [24]
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Intraoperative depth of anaesthesia
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Assessment method [24]
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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.
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Timepoint [24]
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Participants will be followed up during surgery, an estimated duration of 1 hour
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Secondary outcome [25]
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Depth of sedation on the Intensive Care Unit
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Assessment method [25]
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Sedation is measured by Richmond Agitation Sedation Scale.
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Timepoint [25]
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Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
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Secondary outcome [26]
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Sedation on the peripheral ward
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Assessment method [26]
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Sedation is measured by Richmond Agitation Sedation Scale.
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Timepoint [26]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [27]
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Agitation on the peripheral ward
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Assessment method [27]
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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.
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Timepoint [27]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [28]
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Incidence of postoperative delirium
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Assessment method [28]
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Postoperative delirium rate, defined according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), CAM/CAM-ICU, Nu-DESC and Chart Review.
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Timepoint [28]
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Up to 5 days
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Secondary outcome [29]
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Severity of postoperative delirium
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Assessment method [29]
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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).
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Timepoint [29]
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Up to 5 days
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Secondary outcome [30]
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Duration of Delirium
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Assessment method [30]
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Duration of postoperative delirium, defined according to medical evaluation, measured in days
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Timepoint [30]
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Up to intensive care unit discharge, an expected average of 3 days.
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Secondary outcome [31]
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Pain scale for patients able of pain self-assessment
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Assessment method [31]
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Pain during hospital stay will be measured with the Numeric Rating Scale (NRS-V).
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Timepoint [31]
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Up to hospital discharge, an expected average of 5 days
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Secondary outcome [32]
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Pain scales for patients unable of pain self-assessment
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Assessment method [32]
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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.
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Timepoint [32]
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Up to hospital discharge, an expected average of 5 days
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Secondary outcome [33]
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Intensive care unit length of stay
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Assessment method [33]
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Intensive care unit length of stay describes every day spent in an ICU bed.
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Timepoint [33]
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Participants will be followed for the duration of intensive care unit stay, an expected average of 5 days
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Secondary outcome [34]
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Hospital length of stay
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Assessment method [34]
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Hospital length of stay describes every day spent in an hospital.
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Timepoint [34]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [35]
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Perioperative Anxiety
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Assessment method [35]
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Perioperative anxiety will be measured with APAIS preoperatively and the Faces Anxiety Scale (FAS) and during hospital stay.
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Timepoint [35]
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Up to 5 days
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Secondary outcome [36]
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Perception of stress
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Assessment method [36]
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Stress is measured by Perceived Stress Questionnaire 20
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Timepoint [36]
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Up to 5 days
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Secondary outcome [37]
0
0
Stress level
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Assessment method [37]
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Stress level is measured by stress thermometer
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Timepoint [37]
0
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Up to 5 days
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Secondary outcome [38]
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Generalized anxiety
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Assessment method [38]
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Anxiety will be measured with the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
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Timepoint [38]
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Up to 5 days
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Secondary outcome [39]
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Depression
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Assessment method [39]
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Depression is measured by PHQ-8. Scores represent:0-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 16-20 = severe depression
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Timepoint [39]
0
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Up to 5 years
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Secondary outcome [40]
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Quality of sleep
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Assessment method [40]
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Quality of sleep is measured by the Insomnia Severity Index.
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Timepoint [40]
0
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Up to 5 years
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Secondary outcome [41]
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Routine laboratory
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Assessment method [41]
0
0
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Timepoint [41]
0
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Up to hospital discharge, an expected average of 7 days
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Secondary outcome [42]
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Organ dysfunctions
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Assessment method [42]
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Organ dysfunctions are evaluated according to the Clavien-Dindo classification of surgical complications
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Timepoint [42]
0
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Up to hospital discharge, an expected average of 7 days
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Secondary outcome [43]
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Subjective/By proxy assessment of cognitive impairment
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Assessment method [43]
0
0
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Timepoint [43]
0
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Up to five years
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Secondary outcome [44]
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Medication
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Assessment method [44]
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Prescribed regular drug intake from baseline at all follow ups including perioperative application of drugs, infusions and transfusions will be evaluated.
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Timepoint [44]
0
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Up to 5 years
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Secondary outcome [45]
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Quality of life
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Assessment method [45]
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Quality of life will be measured with the EQ-5D-5L
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Timepoint [45]
0
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Up to 5 years
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Secondary outcome [46]
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Level of dependency
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Assessment method [46]
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Level of dependency will be measured with with ADL/IADL, single items concerning patients' living situation and the BSSS-17 (Berlin Social Support Scales).
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Timepoint [46]
0
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Up to 5 years
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Secondary outcome [47]
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0
Plausibility check variables
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Assessment method [47]
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Variables affecting performance of cognitive testings
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Timepoint [47]
0
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Up to 5 years
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Secondary outcome [48]
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Re-admission
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Assessment method [48]
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Hospital readmission is an episode when a patient who had been discharged from a hospital is admitted again within a specified time interval.
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Timepoint [48]
0
0
Up to 5 years
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Secondary outcome [49]
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0
Revison surgery
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Assessment method [49]
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0
Surgery performed to replace or compensate for a failed implant or to correct undesirable sequelae of previous surgery.
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Timepoint [49]
0
0
Up to 5 years
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Secondary outcome [50]
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0
Outpatient treatment
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Assessment method [50]
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0
Treatment outside of the hospital in an associated facility for diagnosis or treatment.
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Timepoint [50]
0
0
Up to 5 years
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Secondary outcome [51]
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Mortality
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Assessment method [51]
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The number of deaths in a given period.
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Timepoint [51]
0
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Up to 5 years
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Secondary outcome [52]
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Dementia
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Assessment method [52]
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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).
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Timepoint [52]
0
0
Up to 5 years
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Secondary outcome [53]
0
0
Motivational incongruence
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Assessment method [53]
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0
The incongruence questionnaire (Der Inkongruenzfragebogen)
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Timepoint [53]
0
0
Up to five years
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Secondary outcome [54]
0
0
Leisure behavior
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Assessment method [54]
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Questionnaire on frequency of cognitively stimulating leisure activities
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Timepoint [54]
0
0
Up to five years
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Secondary outcome [55]
0
0
Demographic variables
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Assessment method [55]
0
0
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Timepoint [55]
0
0
Up to five years
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Secondary outcome [56]
0
0
Living conditions
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Assessment method [56]
0
0
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Timepoint [56]
0
0
Up to five years
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Secondary outcome [57]
0
0
Postoperative electroencephalography (EEG) spectral analysis with band power
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Assessment method [57]
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Spectral analysis with band power are measured by EEG at third postoperative day and delirium dependent until postoperative day 7.
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Timepoint [57]
0
0
Up to seven days
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Secondary outcome [58]
0
0
Evaluation of pain
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Assessment method [58]
0
0
Pain is measured with dolosys paintracker
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Timepoint [58]
0
0
Up to three months
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Secondary outcome [59]
0
0
Loneliness
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Assessment method [59]
0
0
Loneliness is measured with the UCLA-Loneliness-Scale (3 items)
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Timepoint [59]
0
0
Up to five years
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Secondary outcome [60]
0
0
Social support
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Assessment method [60]
0
0
Social support is measured with the Berliner Social-Support Skalen BSSS-17
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Timepoint [60]
0
0
Up to five years
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Secondary outcome [61]
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0
Living situation
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Assessment method [61]
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Living situation is measured with te question: How do you live?
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Timepoint [61]
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Up to five years
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Eligibility
Key inclusion criteria
- Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
- Aged = 70 years
- Informed consent
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Minimum age
70
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/06/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2029
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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0
Germany
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State/province [1]
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0
Berlin
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Funding & Sponsors
Primary sponsor type
Other
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Name
Charite University, Berlin, Germany
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03540433
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Claudia Spies, MD, Prof.
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Address
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0
Charite University, Berlin, Germany
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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0
Claudia Spies, MD, Prof.
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Address
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0
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Country
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0
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Phone
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0
+49 30 450 55 11 02
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Fax
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0
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Email
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0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03540433
Download to PDF