Clinical Outcomes in Elderly Patients With Preoperative Cognitive Dysfunction

Sponsor
Zhongda Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03143595
Collaborator
(none)
500
1
25
20

Study Details

Study Description

Brief Summary

Preexisting cognitive impairment, such as mild cognitive impairment, is common in many elderly patients who undergoing major surgeries. Accumulating evidence has demonstrated that preexisting cognitive impairment is associated with increased mortality, increased incidence of postoperative complications, decreased quality of life, and worse outcomes. However, few studies have evaluated the relationship between preexisting cognitive impairment and cognitive trajectories and clinical outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Preexisting cognitive impairment is common in many elderly patients who undergoing major surgeries. The number of surgical procedures in the elderly will increase dramatically as a result of the increased elderly population in the future. It has been suggested that preexisting cognitive impairment is associated with increased incidence of postoperative complications, decreased quality of life, and increased mortality. Preoperative risk assessment is becoming increasingly important because preoperative risk stratification allows the clinical team to forecast postoperative outcomes. Currently, the most common strategy to identify high-risk patients before surgery is assessment of single end-organ function. This tactic is most widely recognized by the American Heart Association's guideline for cardiac evaluation, but is also well described for pulmonary, hepatic, and renal organ systems. Little is known about the effects of pre-existing cognitive (or brain) function (perhaps the most vital human organ) on postoperative outcomes. Therefore, the present study evaluated whether patients with pre-operative cognitive impairment would have a more precipitous drop in cognitive function and worse outcome in geriatric surgical patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cognitive Trajectories and Clinical Outcomes in Elderly Patients With Preoperative Cognitive Dysfunction
    Actual Study Start Date :
    Jul 1, 2016
    Anticipated Primary Completion Date :
    May 1, 2018
    Anticipated Study Completion Date :
    Aug 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Control group

    Patients in this group have normal cognition as assessed by the validated Mini-Cog test before the elective operation.

    Impaired group

    Patients in this group have impaired cognition as assessed by the validated Mini-Cog test before the elective operation.

    Outcome Measures

    Primary Outcome Measures

    1. Cognition changes [1 year]

      Cognitive function was assessed at baseline before the elective operation and one year in all subjects using the Mini-Cog test by a member of a trained research team.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Inclusion criteria were persons 65 years and older undergoing an elective operation on the general, noncardiac thoracic, urologic, and vascular surgical services.
    Exclusion Criteria:
    • Patients with vision or hearing impairment who could not visualize pictures or hear instructions associated with the delirium assessments and patients who could not provide informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongda Hospital Nanjing Jiangsu China 210009

    Sponsors and Collaborators

    • Zhongda Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jian-jun Yang, Professor, Zhongda Hospital
    ClinicalTrials.gov Identifier:
    NCT03143595
    Other Study ID Numbers:
    • 20160530
    First Posted:
    May 8, 2017
    Last Update Posted:
    May 8, 2017
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jian-jun Yang, Professor, Zhongda Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 8, 2017