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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031316
Receipt No. 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 2019/11/25

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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, 3, 5, 7,and 10 with serial ultrasonographic measurements after ICU admission
Key secondary outcomes The change of following several parameters on days 1, 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

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We consecutively recruited adult patients who were expected to require mechanical ventilation for longer than 48 hours and to remain in the ICU more than 5 days.
Key exclusion criteria We excluded patients who fell under one or more of the following categories: aged less than 20 years old; 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
Email 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
Email nobuto_nakanishi@yahoo.co.jp

Sponsor
Institute Tokushima university hospital
Institute
Department

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
Email 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, and Bioelectrical impedance analysis.

Management information
Registered date
2018 Year 02 Month 15 Day
Last modified on
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035747

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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