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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027054
Receipt No. R000031011
Scientific Title Effect of electrical muscle stimulation in critically ill patients : a randomized study
Date of disclosure of the study information 2017/10/01
Last modified on 2019/04/23

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Basic information
Public title Effect of electrical muscle stimulation in critically ill patients : a randomized study
Acronym Effect of electrical muscle stimulation in critically ill patients
Scientific Title Effect of electrical muscle stimulation in critically ill patients : a randomized study
Scientific Title:Acronym Effect of electrical muscle stimulation in critically ill patients
Region
Japan

Condition
Condition Critically ill patients
Classification by specialty
Intensive care medicine Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of electrical muscle stimulation for preventing upper and lower limbs atrophy of critically ill patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of the upper and lower limb muscle mass atrophy measured by ultrasonography in intensive care patients at day 1 and 5.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Electrical muscle stimulation for 30 minutes/ day until discharge of the ICU.
Interventions/Control_2 No electrical muscle stimulation in the ICU.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients who were expected to be mechanically ventilated longer than 48 hours and to stay more than 5 days in the ICU.
Key exclusion criteria 1 systolic blood pressure < 80 mmHg with catecholamine
2 heart rate < 40/min or >120/min
3 pulse oximetry < 88%
4 fever (>39)
5 receiving intra-aortic balloon pumping
6 primary neuromuscular disease
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Nobuto
Middle name
Last name Nakanishi
Organization Tokushima University Graduate School
Division name Emergency and Critical Care medicine
Zip code 770-8503
Address 2-50-1 Kuramoto, Tokushima, 770-8503, Japan
TEL 088-633-9347
Email nobuto_nakanishi@yahoo.co.jp

Public contact
Name of contact person
1st name Nobuto
Middle name
Last name Nakanishi
Organization Tokushima University Graduate School
Division name Emergency and Critical Care medicine
Zip code 770-8503
Address 2-50-1 Kuramoto, Tokushima, 770-8503, Japan
TEL 088-633-9347
Homepage URL
Email nobuto_nakanishi@yahoo.co.jp

Sponsor
Institute Tokushima University Graduate School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokushima Prefectural Central Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Trial Center for Developmental therapeutics, Tokushima University Hospital
Address 2-50-1 Kuramoto, Tokushima, 770-8503, Japan
Tel 088-633-9294
Email awachiken@tokushima-u.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 徳島大学病院、徳島県立中央病院(1740)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 10 Day
Date of IRB
2017 Year 02 Month 13 Day
Anticipated trial start date
2017 Year 07 Month 10 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 40 patients were included.

Management information
Registered date
2017 Year 04 Month 18 Day
Last modified on
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031011

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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