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History of Changes for Study: NCT03273335
Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, cogniTive Dysfunction and Delirium in Older Adults (INTUIT)
Latest version (submitted November 15, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 3, 2017 None (earliest Version on record)
2 September 5, 2017 Study Description, Study Identification, Conditions and Study Status
3 September 13, 2017 Study Status
4 September 25, 2017 Sponsor/Collaborators, Groups and Interventions, Oversight and Study Status
5 October 24, 2018 Study Status
6 September 6, 2019 Study Status
7 April 20, 2020 Recruitment Status, Study Status and Contacts/Locations
8 July 13, 2020 Recruitment Status, Study Status and Contacts/Locations
9 July 14, 2020 Recruitment Status, Study Status and Contacts/Locations
10 August 7, 2020 Recruitment Status, Study Status and Contacts/Locations
11 December 14, 2020 Study Status
12 November 15, 2021 Recruitment Status, Study Status and Contacts/Locations
13 November 15, 2022 Recruitment Status, Study Status and Study Design
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Study NCT03273335
Submitted Date:  September 3, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: Pro00083288
Brief Title: Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, cogniTive Dysfunction and Delirium in Older Adults (INTUIT)
Official Title: Investigating NeuroinflammaTion UnderlyIng Postoperative Brain Connectivity Changes, cogniTive Dysfunction and Delirium in Older Adults
Secondary IDs: 1K76AG057022 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: September 2017
Overall Status: Recruiting
Study Start: September 10, 2017
Primary Completion: August 3, 2022 [Anticipated]
Study Completion: August 3, 2022 [Anticipated]
First Submitted: September 3, 2017
First Submitted that
Met QC Criteria:
September 3, 2017
First Posted: September 6, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
September 3, 2017
Last Update Posted: September 6, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Miles Berger
Responsible Party: Sponsor-Investigator
Investigator: Miles Berger
Official Title: Assistant Professor of Anesthesiology, Neuroanesthesiology Division
Affiliation: Duke University
Collaborators: National Institute on Aging (NIA)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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. We need strategies to prevent POCD, but first, we need to understand what causes it. A dominant theory holds that brain inflammation causes POCD, but little work has directly tested this theory in humans. Our preliminary data strongly suggest that there is significant postoperative neuro-inflammation in older adults who develop POCD. In this K76 award, we will prospectively obtain pre- and post-operative cognitive testing, fMRI imaging and CSF samples in 200 surgical patients over age 65. This will allow us to evaluate the role of specific neuro-inflammatory processes in POCD and its underlying brain connectivity changes.
Detailed Description:
Open or close this module Conditions
Conditions: Postoperative Cognitive Dysfunction, Delirium
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: CSF, Blood/Serum
Enrollment: 200 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Intervention Details:
n/a, no intervention
n/a, observational, no intervention
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: Surgical patients age 60 and above, as described above.
Sampling Method: Non-Probability Sample
Minimum Age: 60 Years
Maximum Age: 130 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Miles Berger, MD, PhD
Telephone: 919-684-8679
Email: miles.berger@duke.edu
Central Contact Backup: Yanne Toulgoat-Dubois, BA
Telephone: 919-684-5697
Email: yanne.t.dubois@duke.edu
Study Officials: Miles Berger, MD, PhD
Principal Investigator
Duke University
Locations: United States, North Carolina
Duke University Medical Center
[Recruiting]
Durham, North Carolina, United States, 27712
Contact:Contact: Yanne Dubois, BA
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Links:
Available IPD/Information:

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