CompletedNot Applicable

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

Germany173 participantsStarted 2018-06-08

Plain-language 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.

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of postoperative cognitive dysfunction (POCD)

Timeframe: Up to 1 year

Trial details

NCT IDNCT03540433

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Postoperative Cognitive Deficit (POCD) trials