UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To investigate the effectiveness of early mobilization protocol in Japan closed genral ICU
Title of the study (Brief title)	Influence of early mobilization protocol
Region	Japan

Condition
Condition	ICU-AW
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness of early mobilization protocol
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Length of ICU Length of hospital Total Cost
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Introduction of early mobilization protocol
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	To meet the protocol criteria
Key exclusion criteria	Cardiovascular disease Cerebrovascular disease PCAS Pediatrics Can not follow us
Target sample size	200

Research contact person
Name of lead principal investigator	Keibun Liu
Organization	Japan Red Cross Maebashi Hospital
Division name	Advanced Medical Emergency & Critical Care Center
Address	3-21-36 Asahi-cho,Maebashi-shi, Gunma, 371-0014
TEL	027-224-4585
Email	kei--ryu@hotmail.co.jp

Public contact
Name of contact person	Keibun Liu
Organization	Japan Red Cross Maebashi Hospital
Division name	Advanced Medical Emergency & Critical Care Center
Address	3-21-36 Asahi-cho,Maebashi-shi, Gunma, 371-0014
TEL	027-224-4585
Homepage URL
Email	kei--ryu@hotmail.co.jp

Sponsor
Institute	Japan Red Cross Maebashi Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 06 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 15 Day
Anticipated trial start date	2015 Year 06 Month 15 Day
Last follow-up date	2016 Year 06 Month 15 Day
Date of closure to data entry	2016 Year 06 Month 15 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 27 Day
Last modified on	2016 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026385