Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT04792983

Conditions

Cognitive Impairment

Frail Elderly Syndrome

Delirium

Surgery

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

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

Study ID

NCT04792983

Start date

Sep 6, 2019

Status verified date

Mar, 2021

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Older (≥ 65 years of age)

Older surgical patients presenting for elective spine surgery.

Interventions

No intervention

This is an observational study with no interventions.

Primary outcome measure

  • MOCA Score, Delirium, and Plasma Inflammatory Mediators [ Time Frame: 5 years ]
  • MOCA Score, Delirium, and the Cellular Immune Response [ Time Frame: 5 years ]
  • MOCA Score, Delirium and Extracellular Vesicle Immune Responses to Surgery. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Gregory J Crosby, MD

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

Erin J Kim, BA

7034088957ekim56@bwh.harvard.edu

Locations

Brigham & Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sierra J Loomis, BA

617-278-0949saloomis@bwh.harvard.edu

Erin J Kim, BA

6177320949ekim56@bwh.harvard.edu

Principal Investigator:

Gregory J Crosby, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Mar 12, 2021

Last verified

Mar, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2021-03-12.