Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059975) titled 'Developing a System to Predict Delirium Early and Exploring Ways to Prevent It' on April 1.

Study Type: Observational

Primary Sponsor: Institute - Hyogo Medical University

Condition: Condition - Delirium Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - Delirium is a common acute brain dysfunction in hospitalized older adults and is frequently observed not only after surgery but also in emergency care settings. Its symptoms include disturbances in consciousness and attention, disorientation, hallucinations, delusions, and agitation, all of which cause significant distress to patients and impose substantial burdens on families and healthcare providers. Moreover, the occurrence of delirium has been associated with prolonged hospitalization, poor clinical outcomes, long-term cognitive decline, and increased mortality, making it an important clinical challenge.

Multiple risk factors have been identified, including advanced age, preexisting dementia, medical comorbidities, and medication history. However, accurately predicting its onset remains difficult, and no established preventive strategies currently exist. Therefore, it is necessary to identify clinical and biological markers that enable reliable prediction and prevention of delirium.

In this study, we will compare hospitalized patients who experienced delirium with those who did not. After the acute symptoms have stabilized, blood samples will be collected, and information regarding educational background, employment status, marital and living status, current medical history, current medications, and past medication use will be obtained. By analyzing these data, we aim to identify biological characteristics and clinical risk factors associated with the development of delirium and to construct a predictive model.

The findings of this study are expected to contribute to building a system for the early identification of high-risk patients and implementing preventive interventions. Ultimately, this may improve patient safety, enable more efficient use of medical resources, and help prevent the progression of cognitive impairment in hospitalized individuals. Basic objectives2 - Bio-availability

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Patients hospitalized at Hyogo Medical University Hospital whose primary admitting department is the Emergency and Critical Care Center, Neurosurgery, or Cardiovascular Surgery.

Patients who are diagnosed with delirium during hospitalization by a psychiatrist, or patients who do not develop delirium during hospitalization.

Adults aged 20 years or older. Key exclusion criteria - Patients with severe dementia, impaired consciousness, or other conditions that prevent adequate understanding of the study, and whose legally authorized representatives are also unable to provide consent.

Patients for whom blood sampling is considered medically difficult or unsafe (e.g., severe anemia, significant bleeding tendency, end-stage renal failure, or high bleeding risk associated with anticoagulant therapy).

Patients with severe physical illness (e.g., terminal malignancy, advanced organ failure) for whom participation in the study is deemed inappropriate.

Pregnant or breastfeeding women.

Patients whom the investigators judge to be unsuitable for participation in this study. Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 02 Day Anticipated trial start date - 2026 Year 01 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068600

Disclaimer: Curated by HT Syndication.