臨床研究等提出・公開システム

Date of registration	Dec. 27, 2024
Last modified on	Dec. 27, 2024
Trial ID	jRCT1030240589

Scientific Title	Association between the onset of ICU-acquired weakness and early changes in physical function in critically ill patients
Public Title	Association between the onset of ICU-acquired weakness and early changes in physical function in critically ill patients

Contact for Scientific Queries	Name	Hada Yasushi
	Affiliation	University of Tsukuba
	Address	1-1-1, tennodai, tsukuba,ibaraki
	Telephone	+81-29-853-3795
	E-mail	y-hada@md.tsukuba.ac.jp
Contact for Public Queries	Name	Tsubaki Takumi
	Affiliation	University of Tsukuba hosptal
	Address	2-1-1, amakubo, tsukuba,ibaraki
	Telephone	+81-90-2486-9573
	E-mail	tsubaki.takumi.kw@ms.hosp.tsukuba.ac.jp

Recruitment status	Recruiting

Study Design
Anticipated date of first enrollment		Dec. 27, 2024
Actual date of first enrollment		Nov. 01, 2024
Target sample size		100
Study Type		Observational



	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Patient is expected to be intubated and ventilated for 48 hours or more - Patient has a life expectancy of 30 days or more at the time of admission
	Exclusion Criteria	-After scheduled surgery -Persons who have some limitations in their daily lives before hospitalization due to physical or cognitive impairment -Persons with functional disabilities such as limb loss or motor paralysis -Persons with a history of acute brain injury, spinal cord injury, neuromuscular disease, or other illnesses that cause muscle weakness -Persons who are deemed ineligible by a doctor -Persons with language problems that make communication difficult -Persons who have been transferred from a general ward -Persons who have refused to register
	Age Minimum	18age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Critically ill patients
Health Condition(s) Keyword		ARDS, sepsis
Health Condition(s) Code		Critical Illness
Primary Outcome(s)		Presence or absence of ICU-AW onset 14 days after ICU admission
Secondary Outcome(s)		Limb strength, body composition, quadriceps muscle thickness, cross-sectional area, muscle brightness, FSS-ICU

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Tsukuba University Hospital Clinical Research Ethics Committee
Address	2-1-1, Amakubo, Tsukuba, Ibaraki, Ibaraki
Telephone	+81-29-853-3914
E-Mail	t-cledo.adm@un.tsukuba.ac.jp
Approval Status	Approval
Date of approval	Oct. 28, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none