NCT04679259

Brief Summary

Delayed neurocognitive recovery 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 racemase in blood as an indicator of delayed neurocognitive recovery after cardiac surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

January 6, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2025

Completed
Last Updated

January 20, 2026

Status Verified

December 1, 2020

Enrollment Period

4.8 years

First QC Date

December 11, 2020

Last Update Submit

January 15, 2026

Conditions

Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before surgery and at 1, 2, and 7 day after surgery

Secondary Outcomes (3)

  • Concentration of D-serine in blood

    Before surgery and at 1, 2, and 7 day after surgery

  • Concentration of Serine racemase in blood

    Before surgery and at 1, 2, and 7 day after surgery

  • Occurrence of delayed neurocognitive recovery

    Before surgery and at 7 day after surgery

Study Arms (1)

Cardiac surgical patients

EXPERIMENTAL
Diagnostic Test: Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in bloodDiagnostic Test: Neurocognitive testDiagnostic Test: Assessment of delirium

Interventions

Neurocognitive testDIAGNOSTIC_TEST

Neurocognitive test is performed before surgery and at 7 day after surgery

Cardiac surgical patients
Assessment of deliriumDIAGNOSTIC_TEST

Postoperative delirium is assessed daily during 7 days after surgery.

Cardiac surgical patients
Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in bloodDIAGNOSTIC_TEST

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.

Cardiac surgical patients

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective cardiac surgery

You may not qualify if:

  • MMSE \<24
  • History of psychological or neurological diseases
  • Illiteracy
  • Preoperative delirium
  • Vision and hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, Select State/Province, 07061, South Korea

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 22, 2020

Study Start

January 6, 2021

Primary Completion

October 22, 2025

Study Completion

October 29, 2025

Last Updated

January 20, 2026

Record last verified: 2020-12

Locations

KR(1)