UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061235 |
|---|---|
| Receipt number | R000070059 |
| Scientific Title | A Multicenter Prospective Observational Study to Evaluate Inter-facility Variation in Palliative Sedation Practices in Japan |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/10 14:19:48 |
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Basic information
Public title
Inter-facility Variation in Palliative Sedation Practices: A Multicenter Prospective Observational Study in Japan
Acronym
Multicenter Palliative Sedation Practice Variation Study
Scientific Title
A Multicenter Prospective Observational Study to Evaluate Inter-facility Variation in Palliative Sedation Practices in Japan
Scientific Title:Acronym
Palliative Sedation Variation Study
Region
| Japan |
Condition
Condition
Palliative sedation, terminal sedation
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively observe real-world palliative sedation practice across multiple institutions in Japan and to describe inter-facility variation in early post-initiation consciousness assessment and documentation. The primary endpoint is whether a numeric Richmond Agitation-Sedation Scale (RASS) score is explicitly documented in the medical record from 30 to 60 minutes after the initiation of palliative sedation. This endpoint is intended as a documentation-quality/process indicator rather than a direct measure of sedation efficacy. Secondary objectives include describing the format of consciousness documentation at the same time point (scale-based documentation, narrative documentation, or no documentation), documentation of target sedation depth, sedative agents used, initiation patterns, and clinical course within 14 days.
Basic objectives2
Others
Basic objectives -Others
Assessment of inter-facility variation in RASS documentation practice in palliative sedation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Whether a numeric Richmond Agitation-Sedation Scale (RASS) score is explicitly documented in the medical record from 30 to 60 minutes after the initiation of palliative sedation.
Key secondary outcomes
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
Hospitalized patients in eligible wards (general wards or palliative care units) at participating institutions.
Patients in whom palliative sedation is initiated for the relief of refractory suffering at the end of life.
Eligibility is based on the concept of Intent plus Maintenance: sedation must be intentionally initiated for symptom relief and maintained in a sustained or repetitive manner for a certain period.
Intermittent nighttime continuous midazolam may be included when it is considered sedation with maintenance.
Consecutively enrolled cases during the study period at each participating site.
Key exclusion criteria
Sedation primarily administered for intensive or high-dependency care management in the ICU or HCU.
Cases receiving only temporary or single-episode procedure-related or episodic sedation for tests, procedures, or interventions.
Sedation not intended for palliative symptom relief.
Cases lacking the minimum essential baseline information required for the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kawabata |
Organization
Osaka Rosai Hospital
Division name
Department of Palliative Care
Zip code
591-8025
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
TEL
072-252-3561
off.kawabata@gmail.com
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kawabata |
Organization
Osaka Rosai Hospital
Division name
Department of Palliative Care
Zip code
591-8025
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
TEL
072-252-3561
Homepage URL
off.kawabata@gmail.com
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Rosai Hospital
Address
1179-3 Nagasone-cho Kita-ku Sakai city Osaka
Tel
072-252-3561
somuk-osakah@m.johas.go.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 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study without any study intervention. The study population consists of consecutive hospitalized patients in general wards or palliative care units at four participating institutions, in whom palliative sedation is initiated for relief of refractory suffering at the end of life. The main explanatory factor is institution, and the primary outcome is whether a numeric RASS score is explicitly documented from 30 to 60 minutes after sedation initiation. Secondary data include the format of consciousness documentation at the same time point, documentation of target sedation depth, sedative agents, initiation pattern, primary refractory symptom, and clinical course within 14 days. Sampling is based on consecutive case enrollment at each site; no random sampling or case-control sampling is used. All clinical care is left to routine practice at each institution, and no protocol-mandated intervention is introduced by this study.
Management information
Registered date
| 2026 | Year | 04 | Month | 12 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070059
