UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040146 |
|---|---|
| Receipt number | R000045776 |
| Scientific Title | A multicenter prospective observational study on the structured psychotropic drugs intervention for hyperactive delirium in terminally-ill cancer patients |
| Date of disclosure of the study information | 2020/04/13 |
| Last modified on | 2024/04/15 17:07:44 |
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Basic information
Public title
A multicenter prospective observational study on the structured psychotropic drugs intervention for hyperactive delirium in terminally-ill cancer patients
Acronym
The structured psychotropic drugs intervention for hyperactive delirium
Scientific Title
A multicenter prospective observational study on the structured psychotropic drugs intervention for hyperactive delirium in terminally-ill cancer patients
Scientific Title:Acronym
The structured psychotropic drugs intervention for hyperactive delirium
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the feasibility of structured psychotropic drugs intervention for hyperactive delirium in terminally-ill cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients receiving structured psychotropic drugs intervention for hyperactive/mixed delirium at 3 days after (T2). If not, the reason for discontinuation.
Key secondary outcomes
The proportion of patients receiving structured psychotropic drugs intervention for hyperactive/mixed delirium at 1 day (T1), 7days (T3), 14 days (T4), 21days (T5) after and the day of death (T6). If not, the reason for discontinuation.
The proportion of patients who achieved treatment goals at T1 to T6.
The proportion of patients who changed their psychotropic treatment regimen for hyperactive/mixed delirium and their reasons, type and dosage of psychotropic drugs at T1 to T6.
The proportion and reason of patients receiving continuous sedation, type and dosage of sedatives at T1 to T6.
The proportion of patients receiving additional drugs other than psychotropic treatment regimens, reasons for adding other drugs, and types of additional drugs at T1 to T6.
The scores of the Richmond Agitation-Sedation Scale (RASS), Agitation Distress Scale (ADS) item2, Communication Capacity Scale item4, delirium symptoms, and respiratory rate at T1 to T5.
Psychotropic drug-related adverse events at T2 and T3 (CTCAE v5.0)
The outcome at T1 to T5, and 2 months after treatment. (Alive or dead)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hospitalized patients aged 18 years or older.
2) Cancer patients diagnosed as having locally advanced or distant metastases by any of histological, cytological, and clinical diagnosis.
3) Patients who are diagnosed with hyperactive/mixed delirium based on the criteria of DSM-5 and who use psychotropic drugs (injection drug) for restlessness/agitation (RASS + 1 or higher).
4) Delirium is clinically determined by the attending physician to be irreversible.
5) Patients who are examined by a physician in a palliative care unit/palliative care team.
Key exclusion criteria
1) Patients for whom psychotropic drugs are contraindicated.
2) Patients who indicated that they would refuse to participate in this study.
3) Patients judged to be inappropriate by the attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Imai |
Organization
Seirei Mikatahara General Hospital
Division name
Seirei Hospice
Zip code
433-8558
Address
3453 Mikatahara-cho Kita-ku Hamamatsu Shizuoka 433-8558 Japan
TEL
+81534361251
k.imai@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Imai |
Organization
Seirei Mikatahara General Hospital
Division name
Seirei Hospice
Zip code
433-8558
Address
3453 Mikatahara-cho Kita-ku Hamamatsu Shizuoka 433-8558 Japan
TEL
0534361251
Homepage URL
k.imai@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Seirei Mikatahara General Hospital
Address
3453 Mikatahara-cho Kita-ku Hamamatsu Shizuoka 4338558 Japan
Tel
0534361251
mkwebmaster@sis.seirei.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1958
Org. issuing International ID_1
Seirei Mikatahara General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 13 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Research period: January 2020 (after approval by the Ethics Committee)-March 2024 (including the analysis period)
Management information
Registered date
| 2020 | Year | 04 | Month | 13 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045776
