Postoperative Cognitive DysfunctionNCT04679259
Evaluation of Blood Biomarkers as an Indicator of Delayed Neurocognitive Recovery
A study testing Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood, Neurocognitive test and Assessment of delirium in people with Postoperative Cognitive Dysfunction, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood, Neurocognitive test and Assessment of delirium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2021to 29 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective cardiac surgery
Who cannot join
- MMSE <24
- History of psychological or neurological diseases
- Illiteracy
- Preoperative delirium
- Vision and hearing impairment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
SMG-SNU Boramae Medical Center
Seoul, Select State/Province, 07061
About this study
Official title: Evaluation of Blood Biomarkers as an Indicator of Delayed Neurocognitive Recovery After Cardiac Surgery
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.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood, Neurocognitive test, Assessment of delirium
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Neurocognitive testDiagnostic test
Neurocognitive test is performed before surgery and at 7 day after surgery
Assessment of deliriumDiagnostic test
Postoperative delirium is assessed daily during 7 days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgical patients | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before surgery and at 1, 2, and 7 day after surgery
Secondary outcomes (3)
Concentration of D-serine in blood
Blood level of D-serine is assessed.
Measured: Before surgery and at 1, 2, and 7 day after surgery
Concentration of Serine racemase in blood
Blood level of Serine is assessed.
Measured: Before surgery and at 1, 2, and 7 day after surgery
Occurrence of delayed neurocognitive recovery
Neurocognitive assessment
Measured: Before surgery and at 7 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start6 Jan 2021
- Primary completion22 Oct 2025
- Study completion29 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679259
- Sponsor's protocol ID
- 30-2020
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Blood Biomarkers as an Indicator of Delayed Neurocognitive Recovery After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04679259
- Acronym / sponsor ID
- 30-2020
- Conditions
- Postoperative Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgical patients | Experimental | 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective cardiac surgery
Key exclusion criteria (5 listed)
- MMSE <24
- History of psychological or neurological diseases
- Illiteracy
- Preoperative delirium
- Vision and hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in bloodBlood 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 | Cardiac surgical patients |
| Neurocognitive testNeurocognitive test is performed before surgery and at 7 day after surgery | Diagnostic test | Cardiac surgical patients |
| Assessment of deliriumPostoperative delirium is assessed daily during 7 days after surgery. | Diagnostic test | Cardiac surgical patients |
Primary outcome
Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery
Time frame: Before surgery and at 1, 2, and 7 day after surgery
Blood level of D-Amino Acid Oxidase is assessed.
3 secondary outcomes
Concentration of D-serine in blood
Time frame: Before surgery and at 1, 2, and 7 day after surgery
Concentration of Serine racemase in blood
Time frame: Before surgery and at 1, 2, and 7 day after surgery
Occurrence of delayed neurocognitive recovery
Time frame: Before surgery and at 7 day after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood, Neurocognitive test and Assessment of delirium in people with Postoperative Cognitive Dysfunction, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery (time frame: Before surgery and at 1, 2, and 7 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.