Biomarkers Associated With Postoperative Cognitive Dysfunction

NCT ID: NCT05464355

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-05

Study Completion Date

2030-01-31

Brief Summary

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Loss of cognitive function after major surgery is a significant risk in older people. It can occur acutely in the days after surgery as delirium or in months to years later as a persistent reduction in brain function termed neurocognitive decline. Together these conditions are called post operative cognitive dysfunction (POCD). They can be acutely distressing for patients and are associated with other problems after surgery.

The causes of post operative cognitive dysfunction are poorly understood. Studies have been limited by a lack of biomarkers to predict which patients are at high risk of developing POCD. Research suggests silent strokes occurring during surgery and different sensitivities to anaesthetic medicines are associated with POCD.

The project consists of a feasibility study to investigate markers that might predict people over 65 years old getting POCD. The first biomarker is a non-invasive monitor of anaesthetics effects on brain function called electroencephalography (EEG): The investigators will identify which EEG patterns predict delirium within five days surgery. The second set of biomarkers are two blood tests of proteins that increase after strokes: these are neurofilament light chains and tau proteins. The investigators will establish if these can be used to predict having POCD up to one year after surgery and long term cognitive impairment up to 5 years after surgery.

Detailed Description

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Conditions

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Delirium Postoperative Cognitive Dysfunction Cognitive Decline Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Biomarker monitoring

Intraoperative electroencephalography recording

Intervention Type PROCEDURE

Intraoperative electroencephalography measurements, a non-invasive routine monitoring device used during anaesthesia to measure the brain's electrical activity

Neurofilament light chain measurement

Intervention Type PROCEDURE

Measurement of the level of neurofilament light chain in a blood sample

Tau protein measurement

Intervention Type PROCEDURE

Measurement of the level of tau protein in a blood sample

Interventions

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Intraoperative electroencephalography recording

Intraoperative electroencephalography measurements, a non-invasive routine monitoring device used during anaesthesia to measure the brain's electrical activity

Intervention Type PROCEDURE

Neurofilament light chain measurement

Measurement of the level of neurofilament light chain in a blood sample

Intervention Type PROCEDURE

Tau protein measurement

Measurement of the level of tau protein in a blood sample

Intervention Type PROCEDURE

Other Intervention Names

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EEG recording NfL

Eligibility Criteria

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Inclusion Criteria

* Greater than or equal to 65 years of age
* Having elective non-cardiac surgery under general anaesthesia
* Anticipated to have at least 48 hours of inpatient admission
* Able \& willing to give informed consent

Exclusion Criteria

* Unable to participate in neurocognitive assessments
* Presence of delirium prior to surgery
* Contraindication to use of EEG electrodes (e.g. known allergy to a component of the electrodes)
* Known history of severe traumatic brain injury
* Learning disability specifically with a known structural brain lesion
* Known history of dementia
* Participants undergoing operations on the carotid artery
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martyn Ezra

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

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Royal Berkshire NHS Foundation Trust

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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302168

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol version 13/06/2022

Identifier Type: OTHER

Identifier Source: secondary_id

PID16101

Identifier Type: -

Identifier Source: org_study_id

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