UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027079 |
|---|---|
| Receipt number | 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 | 2021/10/28 11:16:58 |
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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
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
kimsato1034@hotmail.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030249
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
