Risk Factor of POD and POCD After Cardiac Surgery

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03635229
Collaborator
(none)
360
Enrollment
1
Location
63.3
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common after surgeries in the elderly, especially after cardiothoracic surgery. These conditions are associated with adverse short- and long-term outcomes.

Multiple conditions in the perioperative period have been proposed as risk factors of POD and POCD.

Incidences vary across institutions due to differences in screening and diagnostic tools.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    This is a prospective observational study to identify the incidences and risk factors of postoperative delirium and postoperative cognitive decline after elderly patients undergoing cardiac surgical procedures which require cardiopulmonary bypass and postoperative intensive care unit (ICU) admission.

    Patients will be screen for POD and POCD with various psychological tests in the postoperative period and after hospital discharge.

    Perioperative data and outcomes will be used to identify risk factors of both conditions.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    360 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Risk Factor of Postoperative Delirium and Postoperative Cognitive Decline After Cardiac Surgery
    Actual Study Start Date :
    Aug 21, 2018
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative delirium [Postoperative day 1-5 (5 consecutive days)]

      A result consistent with postoperative delirium by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period

    Secondary Outcome Measures

    1. Postoperative cognitive dysfunction - postoperative [Postoperative day 5-9 (5 consecutive days)]

      A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)

    2. Postoperative cognitive dysfunction - 3 month [At 3rd month after hospital discharge]

      A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)

    3. Postoperative cognitive dysfunction - 1 year [At 12th month after hospital discharge]

      A result consistent with postoperative cognitive dysfunction by using Montreal Cognitive Assessment (MOCA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age 65 years old or older

    • undergoing open heart surgery (cardiopulmonary bypass assisted cardiothoracic surgery

    Exclusion Criteria:
    • unable to communicate

    • severe visual or hearing impairment

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Siriraj HospitalBangkokThailand10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT03635229
    Other Study ID Numbers:
    • 705/2560(EC1)
    First Posted:
    Aug 17, 2018
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    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 Mahidol University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 22, 2021