Tokyo, June 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061931) titled 'Development of an Innovative Delirium Prediction and Prevention Approach Utilizing AI Monitors, Simplified EEG, and Actigraphy' on June 16.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Saga University

Condition: Condition - delirium Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Although delirium is a critical condition leading to poor prognosis and significant healthcare costs, its underlying pathophysiology remains poorly understood. This study focuses on neuroinflammation, specifically the involvement of microglia in delirium. Using blood samples from patients admitted to the Emergency Care Unit (ECU) or orthopedic ward, we will generate induced microglia-like (iMG) cells. We aim to statistically investigate the role of microglia in delirium by comparing iMG cells between patients who develop delirium and those who do not, focusing on phagocytic activity, Ca2+ dynamics, production of inflammation-related substances, and responsiveness to brain-derived neurotrophic factor (BDNF). The ultimate objective of this study is to establish a foundation for developing novel strategies for the prediction, prevention, and treatment of delirium targeting microglia. (Note: Any secondary use of the data obtained in this study will be conducted only after obtaining separate approval from the Institutional Review Board.) Basic objectives2 - Others

Intervention: Interventions/Control_1 - For patients scheduled for major cardiovascular surgery and ICU admission who provided informed consent, the following sequential interventions and evaluations will be performed:

1. [Screening] Preoperative cognitive function will be assessed using the MMSE; patients scoring 24 or higher will be enrolled. 2. [Preoperative Evaluation] On the morning after admission, a research-specific blood sample (approx. 70 mL) will be collected, and DRS-R98 and MMSE assessments will be performed. That night, a simplified EEG and a wrist-worn activity tracker will be applied. 3. [During ICU Stay] Continuous monitoring via ICU video recording, simplified EEG, and activity tracker will be conducted from ICU admission to discharge (daytime music therapy will be applied upon request). Delirium will be assessed every 8 hours using the CAM-ICU. At the time of suspected delirium onset, or at 48 hours post-awakening without delirium, DRS-R98/MMSE assessments and research-specific blood sampling (approx. 70 mL) will be performed. 4. [Pre-discharge Evaluation] On the day before discharge, DRS-R98/MMSE assessments and blood sampling (approx. 70 mL) will be conducted, followed by overnight simplified EEG and activity tracking.

[Analysis Items] Monocytes isolated from blood samples will be cultured to generate induced microglia-like (iMG) cells for RNA expression analysis. Inflammatory markers (high-sensitivity CRP, IL-1beta, TNF-alpha) will be measured from the remaining serum. EEG, actigraphy, and video recording (motion analysis) data will be utilized for AI-based multi-omics analysis and integrated with clinical data (demographics, medical history, routine laboratory data, and DRS-R98 scores) to develop a delirium prediction model.

Eligibility: Age-lower limit - 70 years-old

Gender - Male and Female Key inclusion criteria - Patients scheduled to undergo elective cardiovascular surgery at our hospital with confirmed subsequent admission to the Intensive Care Unit (ICU).

Patients aged 70 years or older and under 80 years at the time of obtaining informed consent.

Patients (or their legally authorized representatives) who provided written informed consent to participate in this study. Key exclusion criteria - Patients aged under 70 years or 80 years and older.

Patients with cognitive decline, including dementia, defined as a Mini-Mental State Examination (MMSE) score of less than 24 at screening.

Patients with a history of or current alcohol dependence.

Patients with a history or complication of brain disorders, including encephalitis, encephalopathy, traumatic brain injury, or cerebral infarction.

Other patients judged by their primary physician to be inappropriate for participation in this study. Target Size - 36

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 10 Month 01 Day Date of IRB - 2025 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 06 Month 16 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070867

Disclaimer: Curated by HT Syndication.