UMIN-CTR Clinical Trial

Basic information
Public title	muscle volume change by ICU-acquired weakness with/without high dose protein and electrical muscle stimulation
Acronym	protein dose and electrical muscle stimulation for ICU-AW
Scientific Title	muscle volume change by ICU-acquired weakness with/without high dose protein and electrical muscle stimulation
Scientific Title:Acronym	protein dose and electrical muscle stimulation for ICU-AW
Region	Japan

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

Objectives
Narrative objectives1	to investigate the efficacy of protein dose and electrical muscle stimulation for ICU-AW
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	femoral muscle volume change (evaluated by computed tomography)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	In the first period, enteral nutrition after admission is performed by high protein group: Peptamen Intense for ten days.
Interventions/Control_2	In the first period, enteral nutrition after admission is performed by normal group: Glucerna REX for ten days.
Interventions/Control_3	In the latter period, all patients are treated with electrical muscle stimulation, and enteral nutrition after admission is performed by high protein group: Peptamen Intense for ten days.
Interventions/Control_4	In the latter period, all patients are treated with electrical muscle stimulation, and enteral nutrition after admission is performed by normal group: Glucerna REX for ten days.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 admission to ICU 2 age >=20 3 able to perform enteral nutrition 4 get the informed consent
Key exclusion criteria	1 age <20 2 young female who can get pregnant 3 can not get the informed consent 4 the other inadequate patients
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Nakamura
Organization	Hitachi General Hospital
Division name	Emergency and Critical Care Medicine
Zip code	3170077
Address	2-1-1 Jonancho Hitachi Ibaraki Japan
TEL	+81294231111
Email	mamashockpapashock@yahoo.co.jp

Public contact
Name of contact person	1st name Kensuke Middle name Last name Nakamura
Organization	Hitachi General Hospital
Division name	Emergency and Critical Care Medicine
Zip code	3170077
Address	2-1-1 Jonancho Hitachi Ibaraki Japan
TEL	+81294231111
Homepage URL
Email	mamashockpapashock@yahoo.co.jp

Sponsor
Institute	Hitachi General Hospital Emergency and Critical Care Medicine
Institute
Department

Funding Source
Organization	no funding source
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	Hitachi General Hospital
Address	2-1-1 Jonancho Hitachi Ibraki Japan
Tel	0294231111
Email	mamashockpapashock@yahoo.co.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	2018 Year 08 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	134
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	Completed
Date of protocol fixation	2018 Year 08 Month 16 Day
Date of IRB	2018 Year 06 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 16 Day
Last follow-up date	2020 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 16 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038538