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

Completed

• Conditions: Postoperative Delirium

• Registration Number: NCT04194411
• Lead Sponsor: Yonsei University

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

1. 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.

2. 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

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-11
• Study Start: 2020-01-07
• Primary Completion: 2021-12-08
• Study Completion: 2021-12-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	Postoperative 7 days	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of