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Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction

Sponsor
SMG-SNU Boramae Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04679259
Collaborator
(none)
149
Enrollment
1
Arm
24.6
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Dec 21, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jan 10, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery [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 [At 1, 2, and 7 day after surgery]

    Blood level of D-serine is assessed.

  2. Concentration of Serine in blood [At 1, 2, and 7 day after surgery]

    Blood level of Serine is assessed.

  3. The incidence of postoperative cognitive dysfunction [At 7 day after surgery]

    The occurrence of postoperative cognitive dysfunction is evaluated at 7 day after surgery

  4. The incidence of postoperative delirium [Daily for 7 days after surgery]

    The incidence of postoperative delirium is evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients scheduled for elective cardiac surgery
Exclusion Criteria:

  • MMSE <24

  • History of psychological or neurological diseases

  • Illiteracy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • SMG-SNU Boramae Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jin-Young Hwang, Associate professor, SMG-SNU Boramae Medical Center
ClinicalTrials.gov Identifier:
NCT04679259
Other Study ID Numbers:
  • 30-2020
First Posted:
Dec 22, 2020
Last Update Posted:
Dec 22, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Postoperative Cognitive Complications
Cognitive Dysfunction

Study Results

No Results Posted as of Dec 22, 2020