UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031316 |
|---|---|
| Receipt number | R000035747 |
| Scientific Title | Evaluation of limb muscle and diaphragm atrophy in critically ill patients |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2020/08/18 19:50:54 |
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Basic information
Public title
Evaluation of limb muscle and diaphragm atrophy in critically ill patients
Acronym
Limb muscle and diaphragm atrophy
Scientific Title
Evaluation of limb muscle and diaphragm atrophy in critically ill patients
Scientific Title:Acronym
Limb muscle and diaphragm atrophy
Region
| Japan |
Condition
Condition
Patients admitted in the ICU
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of limbs muscle and diaphragm atrophy
Basic objectives2
Others
Basic objectives -Others
Evaluate limb muscle and diaphragm atrophy and functional disabilities to improve nutrition and rehabilitation management in the critically ill patients.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of thickness and cross-sectional area about limb muscle and diaphragm on days 1, 2, 3, 5, 7,and 10 with serial ultrasonographic measurements after ICU admission
Key secondary outcomes
The change of following several parameters on days 1, 2, 3, 5, 7, and 10 after ICU admission
Muscle strength by MRC score
Muscle strength by hand dynamometer
Thickening fraction of diaphragm by ultrasonography
The change of intercostal muscle thickness by ultrasonography
Texture analysis of limb and diaphragm muscle by ultrasonography
Muscle mass by bioelectrical impedance analysis
FSS-ICU and ICU mobility Scale
Titin in urine
Biomarker in urine and blood
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We consecutively recruited adult patients who were expected to remain in the ICU more than 3 days.
Key exclusion criteria
We excluded patients who fell under one or more of the following categories: exhibiting trauma to or amputation of limbs; diagnosed with primary neuromuscular disease.
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima university hospital
Division name
Emergency and critical care medicine
Zip code
770-8503
Address
2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-9347
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima university hospital
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
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Tokushima university hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokushima prefectural central hospital
Name of secondary funder(s)
None
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
awachiken@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2593
Org. issuing International ID_1
Tokushima university hospital
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29110031
Number of participants that the trial has enrolled
28
Results
Biceps brachii thickness and cross-sectional area decreased by 6.5, 11.0, and 13.2% (p < 0.01), and by 8.3, 11.1 and 16.9% on day
3, 5, and 7 (p < 0.01), respectively (Fig. 1). Rectus femoris thickness and cross-sectional area decreased by 7.4, 11.1, and 18.8%, and by 8.7, 13.7, and 20.7% on days 3, 5, and 7 (p < 0.01), respectively.
Results date posted
| 2019 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
Twenty eight patients were enrolled. The mean age was 68 years, 18 males, and median APACHE II score 27.5 (23.0 to 29.3).
Participant flow
Adverse events
None
Outcome measures
The muscle mass of the biceps brachii and rectus femoris were evaluated
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | 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
Muscle mass and function are valuated on days 1, 3, 5, 7, and 10 after ICU admission. We use ultrasonography, hand dynamometer, urinary titin, biomarkers in urine and blood, and Bioelectrical impedance analysis.
Management information
Registered date
| 2018 | Year | 02 | Month | 15 | Day |
Last modified on
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035747
