Association of Plasma Biomarkers for Neurological Injury and Postoperative Delirium After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Delirium is one of the most common complications after cardiac surgeries, incidence of which is 20 70%. Causes and pathophysiology of delirium has not been elucidated yet, however, inflammatory response of the nervous system, imbalance of neurotransmitters and ischemia-reperfusion injury of brain tissue are thought to play a big role. 'Neurofilament light (Nfl)' and 'Tau' are proteins that comprise neurons, which are released into blood during acute brain injury. Increased serum concentrations of these markers are acknowledged to be associated with worse clinical outcomes in patients with acute brain injury. These proteins are also closely linked to degenerative changes in the nervous system and cognitive decline in Alzheimer's disease. Therefore, the increase in blood levels of 'Nfl' and 'Tau' may be related to the development of delirium. The aim of this study is to investigate the association between 'Nfl' and 'Tau', serum markers of damage of the nervous system, and the development of delirium after cardiac surgery.

Detailed Description
-----------------
Assessment of cognitive function and delirium Before the day before surgery, K-MMSE (Korean version of Mini-Mental State Exam) is conducted to check the subjects' baseline cognitive function. From the postoperative day 0 to 7, CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) for mechanically ventilated patients, or 3D-CAM (3-minute diagnostic assessment for delirium using the Confusion Assessment Method) for extubated patients is performed twice a day to assess whether delirium occurs. Records of the nurses are also checked. Measurement of the serum levels of Nfl and Tau Serum concentrations of Nfl and Tau are measured after anesthetic induction, and at postoperative 6 hours

Official Title
-----------------
Association of Plasma Biomarkers for Neurological Injury and Postoperative Delirium After Cardiac Surgery

Conditions
-----------------
Postoperative Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients undergoing valvular heart surgery (>65 years old) Exclusion Criteria: 1. Emergency operation 2. Patients with drug or alcohol abuse 3. Patients with major depressive disorder, major neurocognitive disorder or schizophrenia 4. Patients with schizophrenia 5. Patients who are not able to communicate verbally

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Valve surgery<br>Patients older than 65 years and undergoing elective valvular heart surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium | From the postoperative day 0 to 7, CAM-ICU (for mechanically ventilated patients) or 3D-CAM (for extubated patients) is performed twice a day. Electronic medical records of the patients are also assessed. | Postoperative 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurofilament light, Tau, Delirium, Valvular heart surgery