Developing a System to Predict Delirium Early and Exploring Ways to Prevent It

Development of a Predictive System for Delirium and Evaluation of Preventive Strategies - PREVENT-D Study(Prediction and Prevention of Delirium Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059975

Enrollment

200

Registered

2026-04-01

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Occurrence of delirium during hospitalization (diagnosed at the time of psychiatric consultation based on DSM-5 criteria). Timing of Assessment: During the inpatient period, at the time psychiatric consultation is initiated. Study-related data and samples will be collected after stabilization of delirium symptoms.	—

Secondary

Measure	Time frame
Comparison of clinical variables Age, sex, education, employment, marital/living status, medical history, current illness, medications. Timing: From admission to discharge. Inflammatory biomarker measurements Serum IL-1b, IL-6, IL-18, TNF-a. Timing: After stabilization of delirium symptoms (research blood draw). Gene expression and DNA methylation analyses RNA-Seq and DNA EPIC Array. Timing: Using PBMC-derived RNA/DNA collected after symptom stabilization. Functional analyses of iMG cells Cytokine production, gene expression, morphology. Timing: After completion of the 14-day differentiation period.	—

Measure

Time frame

Comparison of clinical variables Age, sex, education, employment, marital/living status, medical history, current illness, medications. Timing: From admission to discharge. Inflammatory biomarker measurements Serum IL-1b, IL-6, IL-18, TNF-a. Timing: After stabilization of delirium symptoms (research blood draw). Gene expression and DNA methylation analyses RNA-Seq and DNA EPIC Array. Timing: Using PBMC-derived RNA/DNA collected after symptom stabilization. Functional analyses of iMG cells Cytokine production, gene expression, morphology. Timing: After completion of the 14-day differentiation period.

—

Countries

Japan

Contacts

Public ContactKyosuke Yamanishi

Hyogo Medical University Neuropsychiatry

k-yama@hyo-med.ac.jp0798-45-6111

Outcome results