Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction

Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction After Cardiac Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 149
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for elective cardiac surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 1, 2, and 7 day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of D-serine in blood	Blood level of D-serine is assessed.	At 1, 2, and 7 day after surgery
Concentration of Serine in blood	Blood level of Serine is assessed.	At 1, 2, and 7 day after surgery
The incidence of postoperative cognitive dysfunction	The occurrence of postoperative cognitive dysfunction is evaluated at 7 day after surgery	At 7 day after surgery
The incidence of postoperative delirium	The incidence of postoperative delirium is evaluated.	Daily for 7 days after surgery

Collaborators and Investigators

• Sponsor: SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 21, 2020
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): January 10, 2023

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: 30-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No