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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 : Active, not recruiting
First Posted : September 6, 2017
Last Update Posted : November 18, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date September 3, 2017
First Posted Date September 6, 2017
Last Update Posted Date November 18, 2021
Actual Study Start Date June 15, 2017
Actual Primary Completion Date November 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults
Official Title Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, POCD, Delirium in Older Adults
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
CSF, Blood/Serum
Sampling Method Non-Probability Sample
Study Population Surgical patients age 60 and above, as described above.
Condition Delirium
Intervention Device: Millipore biomarker assay plate
Millipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry
Study Groups/Cohorts Surgical patients
Surgical patients will undergo CSF biomarker assays, cognitive testing and fMRI scans.
Intervention: Device: Millipore biomarker assay plate
Publications * Berger M, Murdoch DM, Staats JS, Chan C, Thomas JP, Garrigues GE, Browndyke JN, Cooter M, Quinones QJ, Mathew JP, Weinhold KJ; MADCO-PC Study Team. Flow Cytometry Characterization of Cerebrospinal Fluid Monocytes in Patients With Postoperative Cognitive Dysfunction: A Pilot Study. Anesth Analg. 2019 Nov;129(5):e150-e154. doi: 10.1213/ANE.0000000000004179.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 3, 2017)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 27, 2022
Actual Primary Completion Date November 11, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03273335
Other Study ID Numbers Pro00083288
1K76AG057022 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Duke University
Original Responsible Party Miles Berger, Duke University, Assistant Professor of Anesthesiology, Neuroanesthesiology Division
Current Study Sponsor Duke University
Original Study Sponsor Miles Berger
Collaborators National Institute on Aging (NIA)
Investigators
Principal Investigator: Miles Berger, MD, PhD Duke University
PRS Account Duke University
Verification Date November 2021