UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038353 |
|---|---|
| Receipt number | R000043707 |
| Scientific Title | Evaluation of titin N-fragment in urine as a marker of muscle catabolism in intensive care |
| Date of disclosure of the study information | 2019/10/21 |
| Last modified on | 2019/10/21 17:08:56 |
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Basic information
Public title
Evaluation of titin N-fragment in urine as a marker of muscle catabolism in intensive care
Acronym
Evaluation of titin N-fragment in urine as a marker of muscle catabolism in intensive care
Scientific Title
Evaluation of titin N-fragment in urine as a marker of muscle catabolism in intensive care
Scientific Title:Acronym
Evaluation of titin N-fragment in urine as a marker of muscle catabolism in intensive care
Region
| Japan |
Condition
Condition
post intensive care syndrome
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to assess muscle atrophy in intensive care, imaging tests is performed at present.
We evaluate whether urinary titin fragments, a more objective and minimally invasive muscle catabolism marker, correlate with muscle atrophy associated with intensive care.
Basic objectives2
Others
Basic objectives -Others
To examine whether changes in urinary titin fragment values in patients undergoing intensive care correlate with changes in thigh muscle mass assessed by CT on days 1 and 10.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
correlation between titin fragment in urine and femoral muscle mass change in 10 days evaluated by CT
Key secondary outcomes
correlation between titin fragment in urine and SOFA score, inflammation marker, calorie intake or protein intake
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
ICU admission patients over 20 years old
Patients expected to be hospitalized for 10 days or longer
Patients who have obtained consent from the person or a representative
Key exclusion criteria
Pregnant women
Under 35 years old or women who can get pregnant
Patients without self urine
Patients who have difficulty measuring thigh muscle mass after trauma or amputation
ECMO patients
Other patients who are determined to be inappropriate as subjects by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | nakano |
Organization
Hitachi General Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
317-0077
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
TEL
0294-23-1111
be.rann1988jp@gmail.com
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Nakano |
Organization
Hitachi General Hospital
Division name
Department of Emergency and Critical Care Medicine, Hitachi General Hospital
Zip code
317-0077
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
TEL
0294-23-1111
Homepage URL
be.rann1988jp@gmail.com
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Hitachi General 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
Hitachi General Hospital Institutional Review Board
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
Tel
0294-23-1111
hitachi.chiken.ha@hitachi.com
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
| 2019 | Year | 10 | Month | 21 | 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
| 2019 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 10 | Month | 21 | Day |
Last modified on
| 2019 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043707
| 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 |
