Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03540433




Registration number
NCT03540433
Ethics application status
Date submitted
17/05/2018
Date registered
30/05/2018
Date last updated
13/03/2024

Titles & IDs
Public title
International Observational Study on Perioperative Cognitive Trajectories (POCD Census International/PCI)
Scientific title
Evaluation of POCD-Census Prospective, International Observation Study
Secondary ID [1] 0 0
PCI
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Cognitive Deficit (POCD) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Surgical patients at Campus Virchow- Klinikum and Campus Charité Mitte
* Aged = 70 years
* Informed consent
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
173
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Charite University, Berlin, Germany
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03540433
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Claudia Spies, MD, Prof.
Address 0 0
Charite University, Berlin, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Claudia Spies, MD, Prof.
Address 0 0
Country 0 0
Phone 0 0
+49 30 450 55 11 02
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03540433