International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)

NCT ID: NCT03540433

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 173 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-08
• Study Completion Date: 2024-12-31

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.

Detailed 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.

Conditions

Postoperative Cognitive Deficit (POCD); Neurocognitive Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group

Surgical patients aged ≥70 years

No interventions assigned to this group

Control group

Healthy subjects, aged ≥70 years, American Society of Anesthesiologists (ASA) I+II+III, no surgery

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
• Aged ≥ 70 years
• Informed consent

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)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arbeitsbereich Physikalische Medizin

Berlin, , Germany

Internistische Hausarztpraxis

Berlin, , Germany

Department of Anesthesiology and Intensive Care Medicine Berlin (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

PCI

Identifier Type: -

Identifier Source: org_study_id