UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059975 |
|---|---|
| Receipt number | R000068600 |
| Scientific Title | Development of a Predictive System for Delirium and Evaluation of Preventive Strategies |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/12/04 16:18:36 |
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Basic information
Public title
Developing a System to Predict Delirium Early and Exploring Ways to Prevent It
Acronym
PREVENT-D Study(Prediction and Prevention of Delirium Study)
Scientific Title
Development of a Predictive System for Delirium and Evaluation of Preventive Strategies
Scientific Title:Acronym
PREVENT-D Study(Prediction and Prevention of Delirium Study)
Region
| Japan |
Condition
Condition
Delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | 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 sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | Matsunaga |
Organization
Hyogo Medical University
Division name
Neuropsychiatry
Zip code
6638501
Address
1-1, Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6111
hisa1311@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yamanishi |
Organization
Hyogo Medical University
Division name
Neuropsychiatry
Zip code
663-8501
Address
1-1, Mukogawa, Nishinomiya, Hyogo
TEL
0798-45-6111
Homepage URL
k-yama@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Kyosuke Yamanishi
Funding Source
Organization
Hyogo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1, Mukogawa, Nishinomiya, Hyogo
Tel
0798-45-6111
rinri@hyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Currently in the pre-launch stage.
Management information
Registered date
| 2025 | Year | 12 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068600
