Tokyo, April 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061235) titled 'Inter-facility Variation in Palliative Sedation Practices: A Multicenter Prospective Observational Study in Japan' on April 13.

Study Type: Observational

Primary Sponsor: Institute - Osaka Rosai Hospital

Condition: Condition - Palliative sedation, terminal sedation Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

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 Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 04 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2028 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070059

Disclaimer: Curated by HT Syndication.