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

NCT04194411 | Completed

• 1 other identifier: 4-2019-0925
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

Neurofilament light; Tau; Delirium; Valvular heart surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Valve surgery

Patients older than 65 years and undergoing elective valvular heart surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing valvular heart surgery (\>65 years old)

You may qualify if:

• \. Patients undergoing valvular heart surgery (\>65 years old)

You may not qualify if:

• \. Emergency operation
• \. Patients with drug or alcohol abuse
• \. Patients with major depressive disorder, major neurocognitive disorder or schizophrenia
• \. Patients with schizophrenia
• \. Patients who are not able to communicate verbally

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for Nfl/Tau measurement

MeSH Terms

Conditions

Emergence Delirium; Charcot-Marie-Tooth disease, Type 1F; Pick Disease of the Brain; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: January 7, 2020
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Locations

KR (1)