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

NCT03540433 | Completed

• 1 other identifier: PCI
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 3

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.

Conditions

Postoperative Cognitive Deficit (POCD); Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cognitive dysfunction (POCD)

  Neuropsychological testing

  Up to 1 year

Secondary Outcomes (61)

• Incidence of postoperative cognitive dysfunction (POCD)

  Up to 5 years

• Positive cognitive screening

  Up to 5 years

• Mild Neurocognitive Disorder

  Up to five years

• Major Neurocognitive Disorder

  Up to five years

• Cerobrospinal fluid biomarker for diagnosing dementia

  Up to five years

Other Outcomes (11)

• Obesity 1

  At the beginning of the observation

• Obesity 2

  At the beginning of the observation

• Variables of adjusting

  At the beginning of the observation

Study Arms (2)

Study group

Surgical patients aged ≥70 years

Control group

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

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Surgical patients aged ≥70 years

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (3)

Arbeitsbereich Physikalische Medizin

Berlin, 10117, Germany

Location

Internistische Hausarztpraxis

Berlin, 12163, Germany

Location

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

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: June 8, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)