UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051640 |
|---|---|
| Receipt number | R000058925 |
| Scientific Title | Prediction of physical frailty at hospital discharge in critically ill older patients |
| Date of disclosure of the study information | 2023/07/18 |
| Last modified on | 2023/07/18 20:19:09 |
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Basic information
Public title
Prediction of physical frailty at hospital discharge in critically ill older patients
Acronym
Prediction of physical frailty at hospital discharge in critically ill older patients
Scientific Title
Prediction of physical frailty at hospital discharge in critically ill older patients
Scientific Title:Acronym
Prediction of physical frailty at hospital discharge in critically ill older patients
Region
| Japan |
Condition
Condition
critically ill older patients in ICU
Classification by specialty
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine factors and cutoff values that predict physical frailty at discharge in elderly patients admitted to the ICU.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical frailty at hospital discharge
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Admitted to the ICU from June 2018 to August 2019 and required ventilatory management for at least 48 hours
Key exclusion criteria
(1) length of ICU stay < 72 hours, (2) duration of mechanical ventilatory management < 48 hours, (3) ineligibility for early mobilization and rehabilitation protocols, (4) difficulty walking during hospital admission or before ICU admission, (5) presence of motor paralysis, (6) presence of fracture, and (7) death.
Target sample size
61
Research contact person
Name of lead principal investigator
| 1st name | Nonoyama |
| Middle name | |
| Last name | Tadayoshi |
Organization
University of Fukui Hospital
Division name
Depaetment of Rehabilitation
Zip code
9101193
Address
23-3, Matsuoka-Shimogozuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776613111
nonoyama@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Nonoyama |
| Middle name | |
| Last name | Tadayoshi |
Organization
University of Fukui Hospital
Division name
Department of Rehabilitation
Zip code
9101193
Address
23-3, Matsuoka-Shimogozuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776613111
Homepage URL
nonoyama@u-fukui.ac.jp
Sponsor or person
Institute
UIniversity of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui Hospital Medical Research Support Center
Address
23-3, Matsuoka-Shimogozuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel
0776-61-8614
rinsho-rinri@ml.u-fukui.ac.jp
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
| 2023 | Year | 07 | Month | 18 | 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
61
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective cohort study. The subjects were older patients aged 65 years or older who entered our ICU between June 2018 and August 2019 and required ventilatory management for at least 48 hours.
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058925
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
