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Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT04679259
Recruitment Status : Not yet recruiting
First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Young Hwang, SMG-SNU Boramae Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Diagnostic Test: Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood Diagnostic Test: Neurocognitive test Diagnostic Test: Assessment of delirium Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction After Cardiac Surgery
Estimated Study Start Date : December 21, 2020
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : January 10, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cardiac surgical patients Diagnostic Test: Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood
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.

Diagnostic Test: Neurocognitive test
Neurocognitive test is performed before surgery and at 7 day after surgery

Diagnostic Test: Assessment of delirium
Postoperative delirium is assessed daily during 7 days after surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery [ Time Frame: At 1, 2, and 7 day after surgery ]
    Blood level of D-Amino Acid Oxidase is assessed.


Secondary Outcome Measures :
  1. Concentration of D-serine in blood [ Time Frame: At 1, 2, and 7 day after surgery ]
    Blood level of D-serine is assessed.

  2. Concentration of Serine in blood [ Time Frame: At 1, 2, and 7 day after surgery ]
    Blood level of Serine is assessed.

  3. The incidence of postoperative cognitive dysfunction [ Time Frame: At 7 day after surgery ]
    The occurrence of postoperative cognitive dysfunction is evaluated at 7 day after surgery

  4. The incidence of postoperative delirium [ Time Frame: Daily for 7 days after surgery ]
    The incidence of postoperative delirium is evaluated.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective cardiac surgery

Exclusion Criteria:

  • MMSE <24
  • History of psychological or neurological diseases
  • Illiteracy
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Jin-Young Hwang, Associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier: NCT04679259    
Other Study ID Numbers: 30-2020
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postoperative Cognitive Complications
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
 Mental Disorders
Postoperative Complications
Pathologic Processes