UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050663 |
|---|---|
| Receipt number | R000057516 |
| Scientific Title | Prospective Observational Study of Muscle Elasticity Changes on Ultrasonography in Critically ill Patients |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2024/03/02 13:55:25 |
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Basic information
Public title
Prospective Observational Study of Muscle Elasticity Changes on Ultrasonography in Critically ill Patients
Acronym
Muscle Elasticity Changes on Ultrasonography in Critically ill Patients
Scientific Title
Prospective Observational Study of Muscle Elasticity Changes on Ultrasonography in Critically ill Patients
Scientific Title:Acronym
Muscle Elasticity Changes on Ultrasonography in Critically ill Patients
Region
| Japan |
Condition
Condition
The eligibility criteria are as follows:
Patients admitted to our intensive care unit who are expected to stay in the intensive care unit for more than 3 days,Patients who have obtained written consent from the patient or his/her family members.
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will use ultrasound elastography, which can easily and noninvasively measure the elasticity of muscle tissue as "elastic modulus," to reveal differences in muscle elasticity changes in patients admitted to the ICU and requiring ventilatory management. In particular, we will clarify the changes in elastic modulus associated with the decline in physical function and physiological reserve capacity (Frailty) with aging.
Basic objectives2
Others
Basic objectives -Others
Since this study is an evaluation of whether the echocardiographic index can be used to evaluate muscle, and not an evaluation of the efficacy of the drug, "Others" is selected.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint is the SWE at admission and its variability.
The variability is displayed graphically and the percentage of patients with a variability of 10% or greater is displayed.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The eligibility criteria are as follows:
Patients admitted to our intensive care unit who are expected to stay in the intensive care unit for more than 3 days
Patients who are expected to stay in the intensive care unit for more than 3 days
Patients who have obtained written consent from the patient or his/her family
Key exclusion criteria
1, Patients who cannot give consent for the study.
2, Patients who have difficulty in ultrasound image delineation.
3, Pregnant women
4, Patients who need to be isolated, such as those with new coronavirus infection (because it is impossible to bring the machine into the isolated unit)
5, Patients who have been admitted for more than 3 days and then re-admitted after leaving the room.
6, Other patients deemed unsuitable by the medical staff.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hidehisa |
| Middle name | |
| Last name | Saito |
Organization
Tohoku university
Division name
Department of Anesthesiology and Perioperative Medicine, Tohoku University Graduate School of Medicine
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
hidehisa.saito.e2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yudai |
| Middle name | |
| Last name | Iwasaki |
Organization
Tohoku university
Division name
Department of Anesthesiology and Perioperative Medicine, Tohoku University Graduate School of Medici
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
Homepage URL
yudai.i0213@gmail.com
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
| 2023 | Year | 03 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057516
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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