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Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood
Neurocognitive test
Assessment of delirium
Sponsored by
SMG-SNU Boramae Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Cognitive Dysfunction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for elective cardiac surgery

Exclusion Criteria:

  • MMSE <24
  • History of psychological or neurological diseases
  • Illiteracy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cardiac surgical patients

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery
    Blood level of D-Amino Acid Oxidase is assessed.

    Secondary Outcome Measures

    Concentration of D-serine in blood
    Blood level of D-serine is assessed.
    Concentration of Serine in blood
    Blood level of Serine is assessed.
    The incidence of postoperative cognitive dysfunction
    The occurrence of postoperative cognitive dysfunction is evaluated at 7 day after surgery
    The incidence of postoperative delirium
    The incidence of postoperative delirium is evaluated.

    Full Information

    First Posted
    December 11, 2020
    Last Updated
    December 21, 2020
    Sponsor
    SMG-SNU Boramae Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04679259
    Brief Title
    Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction
    Official Title
    Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction After Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 21, 2020 (Anticipated)
    Primary Completion Date
    December 30, 2022 (Anticipated)
    Study Completion Date
    January 10, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    SMG-SNU Boramae Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Postoperative cognitive dysfunction is defined as a cognitive decline arising after surgery. In the present study, the authors evaluate the level of D-Amino Acid Oxidase, D-serine and Serine in blood as an indicator of postoperative cognitive dysfunction after cardiac surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Cognitive Dysfunction

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    149 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardiac surgical patients
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood
    Intervention Description
    Blood sampling is done before surgery and at 1, 2, and 7 day after surgery. The level of D-Amino Acid Oxidase, D-serine and Serine in blood are assessed.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Neurocognitive test
    Intervention Description
    Neurocognitive test is performed before surgery and at 7 day after surgery
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Assessment of delirium
    Intervention Description
    Postoperative delirium is assessed daily during 7 days after surgery.
    Primary Outcome Measure Information:
    Title
    Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery
    Description
    Blood level of D-Amino Acid Oxidase is assessed.
    Time Frame
    At 1, 2, and 7 day after surgery
    Secondary Outcome Measure Information:
    Title
    Concentration of D-serine in blood
    Description
    Blood level of D-serine is assessed.
    Time Frame
    At 1, 2, and 7 day after surgery
    Title
    Concentration of Serine in blood
    Description
    Blood level of Serine is assessed.
    Time Frame
    At 1, 2, and 7 day after surgery
    Title
    The incidence of postoperative cognitive dysfunction
    Description
    The occurrence of postoperative cognitive dysfunction is evaluated at 7 day after surgery
    Time Frame
    At 7 day after surgery
    Title
    The incidence of postoperative delirium
    Description
    The incidence of postoperative delirium is evaluated.
    Time Frame
    Daily for 7 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for elective cardiac surgery Exclusion Criteria: MMSE <24 History of psychological or neurological diseases Illiteracy

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction

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