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

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 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

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, 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name