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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038353
Receipt No. 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

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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
Email 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
Email be.rann1988jp@gmail.com

Sponsor
Institute Department of Emergency and Critical Care Medicine, Hitachi General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043707

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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