UMIN-CTR Clinical Trial

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
Email	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
Email	ikechi-ygc@umin.ac.jp

Sponsor
Institute	Department of Emergency and Critical Care Medicine, Hitachi general hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051106