UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040292
Receipt No. R000045971
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
Date of disclosure of the study information 2020/05/02
Last modified on 2020/05/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.