UMIN-CTR Clinical Trial

Basic information
Public title	Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness.
Acronym	Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness.
Scientific Title	Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness.
Scientific Title:Acronym	Effects of neuromuscular electrical stimulation on prevention of ICU-acquired weakness.
Region	Japan

Condition
Condition	ICU-acquired weakness
Classification by specialty	Emergency medicine Intensive care medicine Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of neuromuscular electrical stimulation for preventing ICU-acquired weakness in mechanically ventilated patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Daily neuromuscular electrical stimulation knee extension torque
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	For the NMES group, Patients starts NMES therapy to bilateral knee extension muscles (5min/day, 50Hz, input<100mA, pulse amplitude 600 micro sec, 2 sec on-4sec off in 48 hours after admitting to ICU, Interventions continue everyday while patients use ventilator On the first day and the final day in intervention,
Interventions/Control_2	For plasebo group No electronic stimulation therapy On the first day and final day of intervention, in placebo group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients who can start NMES therapy in 48hr after admitting to ICU, and continue it more than 2 days
Key exclusion criteria	under 18 years old, pregnant, BMI over 35, neuromuscular disease patients, Patients who have PM, clinical brain-dead patients, those who can't put electrode on their thigh, etc
Target sample size	54

Research contact person
Name of lead principal investigator	1st name eichi Middle name Last name narimatsu
Organization	Sapporo medical university
Division name	Emergency Medicine
Zip code	0608543
Address	291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Email	enarimat@sapmed.ac.jp

Public contact
Name of contact person	1st name yoichi Middle name Last name katayama
Organization	Sapporo medical university
Division name	Emergency Medicine
Zip code	0608543
Address	291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-611-2111
Homepage URL	https://web.sapmed.ac.jp/tccm/index.html
Email	yoichikata@gmail.com

Sponsor
Institute	Sapporo medical university
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Sapporo medical university
Address	291 S1W16 Chuo-ku, Sapporo, Hokkaido, Japan
Tel	011-611-2111
Email	ji-rskk@sapmed.ac.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	札幌医科大学附属病院救命救急センター

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	Open public recruiting
Date of protocol fixation	2019 Year 12 Month 01 Day
Date of IRB	2019 Year 09 Month 12 Day
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 27 Day
Last modified on	2020 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044238

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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