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

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ClinicalTrials.gov Identifier: NCT03273335
Recruitment Status : Suspended (COVID-19 social distancing requirements)
First Posted : September 6, 2017
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Duke University

Brief Summary:
(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.

Condition or disease Intervention/treatment
Delirium Device: Millipore biomarker assay plate

Detailed Description:
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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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : August 3, 2022
Estimated Study Completion Date : August 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
Surgical patients
Surgical patients will undergo CSF biomarker assays, cognitive testing and fMRI scans.
Device: Millipore biomarker assay plate
Millipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry




Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
CSF, Blood/Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical patients age 60 and above, as described above.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273335


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27712
Sponsors and Collaborators
Duke University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Miles Berger, MD, PhD Duke University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03273335    
Other Study ID Numbers: Pro00083288
1K76AG057022 ( U.S. NIH Grant/Contract )
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders