UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044641 |
|---|---|
| Receipt number | R000050990 |
| Scientific Title | Reliability, validity and responsiveness of the ICU Medical Research Council-sum score and changing of muscle strength in the Intensive Care Unit. |
| Date of disclosure of the study information | 2021/06/24 |
| Last modified on | 2021/12/23 10:57:37 |
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Basic information
Public title
Reliability, validity and responsiveness of the ICU Medical Research Council-sum score and changing of muscle strength in the Intensive Care Unit.
Acronym
Reliability, validity and responsiveness of the ICU Medical Research Council-sum score and changing of muscle strength in the Intensive Care Unit.
Scientific Title
Reliability, validity and responsiveness of the ICU Medical Research Council-sum score and changing of muscle strength in the Intensive Care Unit.
Scientific Title:Acronym
Reliability, validity and responsiveness of the ICU Medical Research Council-sum score and changing of muscle strength in the Intensive Care Unit.
Region
| Japan |
Condition
Condition
Patients who admitted in the ICU
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect reliability, validity and responsiveness of the ICU Medical Research Council-sum score in the Intensive Care Unit.
Basic objectives2
Others
Basic objectives -Others
To detect changing of muscle strength in the Intensive Care Unit.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The intra-class correlation coefficient on the MRC score at Initial Assessment.
Key secondary outcomes
MRC and Handgrip Strength at Initial, ICU discharge and Hospital discharge.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All mechanical ventilated patients in the ICU
Key exclusion criteria
1. under 18 years old
2. ICU stay <48 hours
3. Extubated within 48 hours after ICU admission
4. Unclear consciousness during 5 days after ICU admission
5. Neuro patients
6. Cannot get Patient's consent
7. Richmond agitation sedation scale (RASS) at muscle strength assessment of less than -3 and +2 or more.
8. Patients using muscle relaxants
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Katsukawa |
Organization
Yonemori Hospital
Division name
Rehabilitation
Zip code
890-0062
Address
1-17-1 Yojiro Kagoshima- City Kagoshima, Japan
TEL
099-230-0100
winegood21@gmail.com
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Katsukawa |
Organization
Yonemori Hospital
Division name
Rehabilitation
Zip code
890-0062
Address
1-17-1 Yojiro Kagoshima- City Kagoshima, Japan
TEL
099-230-0100
Homepage URL
winegood21@gmail.com
Sponsor or person
Institute
Yonemori 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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yonemori Hospital
Address
1-17-1 Yojiro Kagoshima- City Kagoshima, Japan
Tel
099-230-0100
n-sugiyasu@yk2.so-net.ne.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
| 2021 | Year | 06 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050990
| 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 |
