UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044755 |
|---|---|
| Receipt number | R000051106 |
| Scientific Title | Predictive risk factors for functional decline in elderly patients with non-critical trauma |
| Date of disclosure of the study information | 2021/07/04 |
| Last modified on | 2021/08/19 12:21:12 |
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Basic information
Public title
Predictive risk factors for functional decline in elderly patients with non-critical trauma
Acronym
PREDICT study
Scientific Title
Predictive risk factors for functional decline in elderly patients with non-critical trauma
Scientific Title:Acronym
PREDICT study
Region
| Japan |
Condition
Condition
non-critical traumatic patient over 70 years old(ISS<16)
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To create an early prediction tool for PACS that is easy to objectively evaluate and can serve as an indicator for appropriate early rehabilitation and nutritional intervention for elderly patients hospitalized for non-critical trauma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PACS(clinical outcome, physical function)
Key secondary outcomes
Survival rate, length of hospital stay, mental
and cognitive function (EQ-5d, HADS, SMQ)
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Elderly patietnts with non-critical trauma(ISS<16) aged 70 years and older
Patients who are expected to be hospitalized for more than 3 days
Key exclusion criteria
Patients who died within 3 days
Patients with thigh trauma or infection that makes it difficult to accurately measure muscle mass by ultrasound
Patients who are anuric or on dialysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ikechi |
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
ikechi-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ikechi |
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
Homepage URL
ikechi-ygc@umin.ac.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Hitachi general hospital
Institute
Department
Personal name
Funding Source
Organization
ZENKYOREN (National Mutual Insurance Federation of Agricultural Cooperatives)
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
Research Ethics Committee of Corporate Hospital Group, Hitachi, Ltd.
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
Tel
0294231111
masahiro.miura.cz@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
| 2021 | Year | 07 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Research Design)
Cohort study
(Patients)
All patients who entered our Emergency Center between July 5, 2021 and March 31, 2022 and managed by our department, and met the selection criteria.
Management information
Registered date
| 2021 | Year | 07 | Month | 04 | Day |
Last modified on
| 2021 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051106
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
