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

Sponsor
Duke University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03273335
Collaborator
National Institute on Aging (NIA) (NIH)
200
1
65.4
3.1

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Anticipated 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 :
Jun 15, 2017
Actual Primary Completion Date :
Nov 11, 2021
Anticipated Study Completion Date :
Nov 27, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Correlation between Perioperative changes in CSF Monocytes and perioperative changes in cognition (continuous cognitive index change) [from before to 6 weeks after anesthesia/surgery]

    as above

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 130 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27712

Sponsors and Collaborators

  • Duke University
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Miles Berger, MD, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03273335
Other Study ID Numbers:
  • Pro00083288
  • 1K76AG057022
First Posted:
Sep 6, 2017
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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:

Study Results

No Results Posted as of Nov 18, 2021