Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults

(From NIH reporter) Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27712, United States

About this study

Each year >16 million older Americans undergo anesthesia and surgery, and up to 40% of these patients develop postoperative cognitive dysfunction (POCD), a syndrome of postoperative thinking and memory deficits. Although distinct from delirium, POCD (like delirium) is associated with decreased quality of life, long term cognitive decline, early retirement, increased mortality, and a possible increased risk for developing dementia such as Alzheimer's disease. Understanding the etiology of POCD will likely help promote strategies to treat and/or prevent it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. The preliminary data of this team strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, the investigators will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow the investigators to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 60 and above
Having surgery scheduled to last > or = to 2 hours at Duke University Medical Center (ie Duke Hospital, Duke Medicine Pavilion, Duke Regional Hospital, Durham VA, Duke Raleigh Hospital)

Exclusion criteria

Anticoagulants (per ASRA guidelines)
Current use of chemotherapeutic agents with known cognitive effects.

Treatment and study plan

Millipore biomarker assay plate

Device

Millipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry

Primary outcomes

Correlation between Perioperative changes in CSF Monocytes and perioperative changes in cognition (continuous cognitive index change)

Time frame: from before to 6 weeks after anesthesia/surgery

as above

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

National Institute on Aging (NIA)

Registry information

Acronym: INTUIT

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2022
First posted: Sep 6, 2017
Registry last updated: Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed