UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 04 Month 20 Day
Date of IRB	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 04 Month 25 Day
Last follow-up date	2019 Year 09 Month 11 Day
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	2021 Year 10 Month 28 Day

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