Cognition and the Immunology of Postoperative Outcomes

NCT04792983 | Unknown

• 1 other identifier: 2019P000577
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This research will test the hypothesis that immune system disequilibrium / dysfunction explains why preoperative cognitive impairment is a strong predictor of postoperative morbidity in older surgical patients. The investigators propose that cognitive impairment influences surgical morbidity because of underlying immune disequilibrium / dysfunction (risk marker) and that this shapes the immune response to surgery and defines immunological hallmarks of postoperative morbidity (disease marker). The overarching goal of this application therefore is to define and better understand the clinical immunology underlying the relationship between cognition and geriatric surgical morbidity.

Conditions

Cognitive Impairment; Frail Elderly Syndrome; Delirium; Surgery

Keywords

postoperative health outcomes; older surgical patients; delirium; spine surgery

Outcome Measures

Primary Outcomes (3)

• MOCA Score, Delirium, and Plasma Inflammatory Mediators

  The investigators will evaluate correlations between preoperative cognition, as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative plasma inflammatory markers by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.

  5 years

• MOCA Score, Delirium, and the Cellular Immune Response

  The investigators will evaluate correlations between preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative monocyte immune gene transcriptome ex vivo to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.

  5 years

• MOCA Score, Delirium and Extracellular Vesicle Immune Responses to Surgery.

  The investigators will evaluate correlations between poor preoperative cognition as measured by the Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) with the development of postoperative delirium and measure preoperative and postoperative proteins found in circulating extracellular vesicles by ELISA to identify whether they correlate with either the MOCA score and/ or the development of postoperative delirium.

  5 years

Secondary Outcomes (8)

• Newly diagnosed perioperative health complications

  Up to 30 days after the surgical procedure

• Discharge location (Home vs. other than home) on the day of patient discharge from hospital

  Up to 30 days after the surgical procedure

• 30 day mortality

  30 days after surgical procedure

• 30 day re-operation or readmission

  30 days after surgical procedure

• 6 month mortality

  6 months after surgical procedure

Study Arms (1)

Older (≥ 65 years of age)

Older surgical patients presenting for elective spine surgery.

Other: No intervention

Interventions

No intervention OTHER

This is an observational study with no interventions.

Older (≥ 65 years of age)

Eligibility Criteria

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

Study Population

The cohort will consist of 600 consenting subjects ≥ 65 years of age who present for preoperative evaluation prior to elective spine surgery.

You may qualify if:

• Patients ≥ 65 years of age
• American Society of Anesthesiologists (ASA) physical status of I-III
• Scheduled for elective spine surgery.

You may not qualify if:

• History of stroke (not including transient ischemic attacks, or TIAs)
• History of brain tumor
• History of autoimmune disorders
• Medications likely to significantly impact inflammation (e.g. steroids)
• Current infection
• Uncorrected vision or hearing impairment
• limited use of the dominant hand (limited ability to draw)
• inability to speak, read, or understand English.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, isolated white blood cells, and whole blood

MeSH Terms

Conditions

Cognitive Dysfunction; Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregory J Crosby, MD

  Brigham & Women's Hospital; Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory J Crosby, MD

CONTACT

617-732-7398; gcrosby@bwh.harvard.edu

Erin J Kim, BA

CONTACT

7034088957; ekim56@bwh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 11, 2021
• Study Start: September 6, 2019
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2025
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

US (1)