AzTrials
AzTrials

Cognitive ImpairmentNCT04792983

Cognition and the Immunology of Postoperative Outcomes

An observational study of Cognitive Impairment and Frail Elderly Syndrome, run by Brigham and Women's Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
How many people
600 participants
Where
1 siteUnited States
Study dates
6 Sep 2019to 31 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Gregory J Crosby, MD contact

617-732-7398

gcrosby@bwh.harvard.edu

Erin J Kim, BA contact

7034088957

ekim56@bwh.harvard.edu

United States1 site, 1 recruiting
  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

    Sierra J Loomis, BA, 617-278-0949, saloomis@bwh.harvard.edu

    Erin J Kim, BA, 6177320949, ekim56@bwh.harvard.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This project is designed as a prospective, single-center observational study. The cohort will consist of 600 consenting subjects ≥ 65 years of age that agree to have a study investigator speak with them during their preoperative evaluation prior to elective spine surgery. These ages are chosen as significant clinical data demonstrate increased cognitive impairment in community dwelling elders. Eligibility criteria include: patients ≥ 65 years of age with an American Society of Anesthesiologists (ASA) physical status classification of I-III presenting for elective spinal surgery. Exclusion criteria will include history of stroke (not including transient ischemic attacks, or TIAs) or brain tumor, a history of autoimmune disorders, medications likely to significantly impact inflammation (e.g. steroids), current infection, uncorrected vision or hearing impairment (unable to see pictures or read or hear instructions); limited use of the dominant hand (limited ability to draw); and or inability to speak, read, or understand English.

Patients will be introduced to the study through a flyer provided to them as part of a packet from their surgeon's office. A study team member will speak with those who have agreed during their preoperative evaluation to discuss studies from the department of Anesthesiology and satisfy eligibility criteria. After obtaining informed verbal consent over the telephone, study staff will gain information about the patient's age and years of education. Study staff will conduct the following preoperative measures over the telephone: the Geriatric Depression Scale-Short (GDS), the Beck Anxiety Inventory (BAI), the Visual Analog Scale for Pain (VAS), the Fatigue, Resistance, Ambulation, Illness, and Loss of Weight scale (FRAIL), Instrumental Activities of daily living (IADLs), the Brief Pain Inventory (BPI), the World Health Organization Disability Assessment Schedule (WHODAS). In addition, all patients will be asked if they've had a fall within the last 6 months, whether they've been evaluated for a change in memory or thinking, who accompanied them to their appointment, their employment status and their living situation (alone, institutionalized, living with family members), and whether they have ever tested positive for COVID-19 in a patient survey. The study staff will administer the Montreal Cognitive Assessment (MOCA) simple cognitive screening tool that takes less than 10 minutes to complete and has little or no education, language, or race bias. Frailty will be measured using the Frail Scale. Other measures of cognitive impairment will be obtained by study staff through: documentation on the patient's standard preoperative form, patient or informant report of diagnosis or evaluation for cognitive impairment or memory concerns, and systematic medical record review. Each enrolled patient will be advised to expect a follow up telephone up to 3, 6, and 12- months after surgery to verify data elements and reassess functional outcome.

Delirium will be assessed prospectively once per day on postoperative days 1, 2, and/or 3 by a trained study team member using the Confusion Assessment Method [CAM] if the patient remains in the hospital and agrees to the evaluation. Delirium by chart review and CAM-ICU scores from the nursing staff will also be documented. Delirium is most common on postoperative days 1-3 and the CAM is a well-validated measure of delirium in surgical patients. To evaluate cognition and functional status, the MOCA and the WHODAS will be administered 3, 6, and 12- months postoperatively by study staff over the telephone if the patient can be contacted and continue to agree to participate. The investigators will also collect information on secondary outcomes including whether they had a surgical procedure, time to postoperative anesthesia care unit (PACU) discharge, discharge to place other than home (rehabilitation, skilled nursing facility), hospital length of stay (LOS), 30-day reoperation or readmission rate, and 30-day, 6-month, and 1-year mortality when available. These outcomes are recorded in the medical record, the BWH Balanced Scorecard, an electronic database of all hospitalized patients that tabulates 31 elements of the hospital event, or the Brigham and Women's Hospital BWH Research Patient Database Enhanced Query. Data will also be confirmed by a follow up telephone interview.

Being tested
No intervention
Keywords
postoperative health outcomes, older surgical patients, delirium, spine surgery
Medical subject headings
Cognitive Dysfunction, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    This is an observational study with no interventions.

Study groups in NCT04792983
Study groupRoleWhat they receive
Older (≥ 65 years of age)Older surgical patients presenting for elective spine surgery.
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. 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.

    Measured: 5 years

Secondary outcomes (8)
  1. Newly diagnosed perioperative health complications

    Newly diagnosed Myocardial Infarction, congestive heart failure (CHF), Cardiac Arrest, Arrythmia, Pneumonia, pulmonary embolism (PE), Reintubation, Stroke, Delirium, Coma>24h, deep wound infection,Superficial wound infection, Sepsis, Renal Failure, urinary tract infection (UTI), Reoperation, deep vein thrombosis (DVT), intensive care unit (ICU) admission following the subjects initial surgical procedure.

    Measured: Up to 30 days after the surgical procedure

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

    Whether the patient was discharge to their home or discharged to a place other than home such as rehabilitation center or skilled nursing facility.

    Measured: Up to 30 days after the surgical procedure

  3. 30 day mortality

    Patient mortality 30 days after surgical procedure

    Measured: 30 days after surgical procedure

  4. 30 day re-operation or readmission

    Patient readmission to the hospital or reoperation 30 days after surgical procedure

    Measured: 30 days after surgical procedure

  5. 6 month mortality

    Patient mortality 6 months after surgical procedure

    Measured: 6 months after surgical procedure

  6. 1 year mortality

    Patient mortality 1 year after surgical procedure

    Measured: 1 year after surgical procedure

  7. Cognitive health outcome

    Montreal Cognitive Assessment (MOCA, minimum score 0 maximum score 30, with higher scores suggesting better cognitive performance) measured approximately 3, 6, and 12-months following the patient's surgical procedure if the participant is willing to participate.

    Measured: 3, 6, and 12-months after surgical procedure.

  8. Functional health outcome

    Functional health outcome measured with the World Health Organization Disability Assessment Score (WHODAS, 12-item, minimum score 0 maximum score 110 with higher score reflecting more disability) approximately 6 months to 1 year following the patient's surgical procedure if the participant can be contacted by followup phone call and is willing to participate.

    Measured: Between 6 and 12-months after surgical procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start6 Sep 2019
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04792983
Sponsor's protocol ID
2019P000577
Status last verified
Mar 2021
First submitted
26 Feb 2021
Last updated
12 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Impairment and Frail Elderly Syndrome, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gregory J Crosby, MD (617-732-7398, gcrosby@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MOCA Score, Delirium, and Plasma Inflammatory Mediators (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in