UMIN-CTR Clinical Trial

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