臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 11, 2021
Last modified on	Mar. 11, 2021
Trial ID	jRCTs041200112

Scientific Title	Preventive effect of ramelteon on delirium in ICU
Public Title	Preventive effect of ramelteon on delirium in ICU

Contact for Scientific Queries	Name	Numaguchi Atushi
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya city, Aichi
	Telephone	+81-52-744-2659
	E-mail	nummer0116@gmail.com
Contact for Public Queries	Name	Numaguchi Atushi
	Affiliation	Nagoya University Hospital
	Address	65 Tsurumai-cho, Showa-ku, Nagoya city, Aichi
	Telephone	+81-52-744-2659
	E-mail	nummer0116@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 11, 2021
Actual date of first enrollment
Target sample size		220
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) ICU patients 18 years old or more, expected to stay in ICU for over 48 hours. 2) Patients registered within 48hours of ICU admission and administrated first medication on the registration day.
	Exclusion Criteria	1) Patients under 18 years old. 2) Allergy to ramelteon. 3) Patients with severe liver injury (T-Bil >= 10 mg/dL, or ALT >= 750 IU/L). 4) Patients receiving fluvoxamine maleate. 5) Patients already receiving ramelteon therapy before admission. 6) Patients expected to leave ICU within 48 hours of admission. 7) Patients expected to die within 48 hours of admission or be excluded from active treatment. 8) Pregnant or lactating women. 9) Patients expected to be difficult to evaluate delirium by CAM-ICU due to neurological problems such as post-cardiac arreest, head trauma, stroke, or other illness. 10) Absence of written informed consent.
	Age Minimum	40age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients who need ICU management.
Intervention(s)		Arm ramelteon: Over-encapsulated ramelteon (8 mg) given either orally or via nasogastric tube at 20:00 hours for 14 consecutive nights or until ICU discharge, whichever occurs first. Arm placebo: Over-encapsulated maltitol given either orally or via nasogastric tube at 20:00 hours for 14 consecutive nights or until ICU discharge, whichever occurs first.
Health Condition(s) Keyword		intensive care
Intervention(s) Keyword		Ramelteon
Health Condition(s) Code		D007362
Intervention(s) Code		D000284
Primary Outcome(s)		Occurrence of ICU-delirium
Secondary Outcome(s)		Length of delirium, severity and need for treatment of delirium, length and quality of sleep, length of ICU and hospital stay, 28- and in-hospital mortality, ventilator free days (number of days without ventilator use from day 1 to day 28), dose of sedative drugs.

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japanese association for acute medicine
Secondary Sponsor	Applicable

Name of Certified Review Board	Nagoya University Clinical Research Review Board
Address	65 Tsurumai-cho, Showak-ku, Nagoya city, Aichi, JAPAN, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 02, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none