UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of acute phase intervention in elderly patients with mild trauma on muscle mass maintenance and muscle catabolism biomarker : randomized controlled trial
Acronym	The efficacy of acute phase intervention in elderly patients with mild trauma on muscle mass maintenance and muscle catabolism biomarker : randomized controlled trial
Scientific Title	The efficacy of acute phase intervention in elderly patients with mild trauma on muscle mass maintenance and muscle catabolism biomarker : randomized controlled trial
Scientific Title:Acronym	The efficacy of acute phase intervention in elderly patients with mild trauma on muscle mass maintenance and muscle catabolism biomarker : randomized controlled trial
Region	Japan

Condition
Condition	elderly patients admitted with mild trauma
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of efficacy of acute phase intervention on muscle mass change and physical function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	femoral muscle volume change from day 1 through 14
Key secondary outcomes	Chage of Barthel Index and lower leg circumference from day1 through 14 N-titin level of days 1 and 3

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Nutritional supplement containing HMB are given to intervention group twice a day for 14 days, while providing adequate nutrition and early rehabilitation during hospitalization.
Interventions/Control_2	Nutritional supplement without HMB are given to the control group twice a day for 14 days, while providing adequate nutrition and early rehabilitation during hospitalization.
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients admitted to the emergency department for trauma with ISS <16 Patients expected to be hospitalized for 3 days or more Patients who have obtained consent from the person or a representative
Key exclusion criteria	Non dialysis patients with Cre >3 Patients with anuria 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	0294231111
Email	be.rann1988jp@gmail.com

Public contact
Name of contact person	1st name Hidehiko Middle name Last name Hidehiko
Organization	Hitachi General Hospital
Division name	Department of Emergency and Critical Care Medicine
Zip code	3170077
Address	2-1-1, Jonancho, Hitachi, Ibaraki, Japan
TEL	0294231111
Homepage URL
Email	be.rann1988jp@gmail.com

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

Funding Source
Organization	The General Insurance Association of Japan
Organization
Division
Category of Funding Organization	Non profit foundation
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	0294231111
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	2020 Year 05 Month 02 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 09 Month 11 Day
Date of IRB	2019 Year 10 Month 15 Day
Anticipated trial start date	2019 Year 11 Month 01 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

Management information
Registered date	2020 Year 05 Month 02 Day
Last modified on	2020 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045971

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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