Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03540433
Study type Observational
Source Charite University, Berlin, Germany
Contact
Status Active, not recruiting
Phase
Start date June 8, 2018
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05754567 - CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Not yet recruiting NCT03276377 - VItamin K Inhibition and NeurocoGnition (VIKING) N/A
Completed NCT04175223 - Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders N/A
Completed NCT03538522 - A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831 Phase 2
Recruiting NCT05732285 - A Pilot Randomized Controlled Trial: CoINTEGRATE N/A
Recruiting NCT04095962 - Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia N/A
Not yet recruiting NCT04113577 - COgilus Remediation in Alzheimer Patients (CORA)
Recruiting NCT06320639 - DRIVing Simulator and People With NeuroCognitive Disorders
Recruiting NCT06105320 - COGNIFOOD-Changing the Carbohydrate/Fat-ratio to Prevent Cognitive Decline and Alzheimer Pathology: A Pilot Study N/A
Completed NCT03050385 - Cognitive Rehabilitation During Transcranial Direct Current Stimulation N/A
Active, not recruiting NCT06372002 - Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia N/A
Recruiting NCT05508789 - A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) Phase 3
Recruiting NCT03926351 - High Dose Omega 3 in People at Risk for Dementia Phase 2
Recruiting NCT05504681 - Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic
Completed NCT04168268 - Patient-reported Outcome Measures After Post-anesthesia Care Unit Delirium
Recruiting NCT04825847 - Neurocognitive Disorders After Major Surgery in Elderly N/A
Active, not recruiting NCT02958670 - Imaging Tau Deposition in the Brain of Elderly Subjects N/A
Enrolling by invitation NCT02652598 - Evaluate the Effects of Tolcapone on Cognitive and Behavioral Dysfunction in Patients With BI and NCD Phase 2
Completed NCT02825732 - MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint N/A