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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027079
Receipt No. R000030249
Scientific Title Neuromuscular ultrasound and biomarker for intensive care unit-acquired weakness
Date of disclosure of the study information 2017/04/25
Last modified on 2017/10/22

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Basic information
Public title Neuromuscular ultrasound and biomarker for intensive care unit-acquired weakness
Acronym Neuromuscular ultrasound and biomarker for intensive care unit-acquired weakness
Scientific Title Neuromuscular ultrasound and biomarker for intensive care unit-acquired weakness
Scientific Title:Acronym Neuromuscular ultrasound and biomarker for intensive care unit-acquired weakness
Region
Japan

Condition
Condition Patients in intensive care unit
Classification by specialty
Medicine in general Surgery in general Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 ICU-acquired weakness is difficult to diagnose early and correctly with currently developed examinations, which might result in late diagnosis and worse outcomes of the patients. This study aims to assess the effectiveness of neuromuscular ultrasound and muscle biomarker for the disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sensitivity and specificity of neuromuscular ultrasound for the diagnosis in 10 days in ICU, compared with electrophysiological testing
Key secondary outcomes 1. Comparison of muscle biomarker with electrophysiological testing
2. Comparison of neuromuscular ultrasound with muscle strength
3. Change of assessment using neuromuscular ultrasound and muscle biomarker over time in ICU
4. Independent risk factors of ICU-acquired weakness

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Electrophysiological testing, neuromuscular ultrasound, measurements of muscle biomarker for ICU-acquired weakness for up to ten days after admission to ICU
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Admission to ICU in Okayama University Hospital in April 2017 to July 2018
Expected length of stay in ICU >=4 days
Key exclusion criteria Pregnancy
BMI>35kg/m2
Paralysis, hemiplesia
Amputation of lower limbs
Muscle-oriented diseases
Metal allergy
Patients who stayed in ICU over three months
Extensive burn
Patients who are expected to have difficulty in examining electrophysiological testing or muscle ultrasound

Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kimura
Organization Okayama University Hospital
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama-shi, Okayama
TEL 086-223-7151
Email kimsato1034@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Kimura
Organization Okayama University Hospital
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama-shi, Okayama
TEL 086-223-7151
Homepage URL
Email kimsato1034@hotmail.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization None for aid for Scientific Research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 04 Month 25 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
2017 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 20 Day
Last modified on
2017 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030249

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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