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

NCT03273335 | Completed DMC FDA Device

• 2 other identifiers: Pro000832881K76AG057022
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

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

  as above

  from before to 6 weeks after anesthesia/surgery

Study Arms (1)

Surgical patients

Surgical patients will undergo CSF biomarker assays, cognitive testing and fMRI scans.

Device: Millipore biomarker assay plate

Interventions

Millipore biomarker assay plate DEVICE

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

Surgical patients

Eligibility Criteria

• Age: 60 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Surgical patients age 60 and above, as described above.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27712, United States

Location

Related Publications (1)

• 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.

  PMID: 31085945 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

CSF, Blood/Serum

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Miles Berger, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2017
• First Posted: September 6, 2017
• Study Start: June 15, 2017
• Primary Completion: November 11, 2021
• Study Completion: October 21, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

US (1)