UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047941 |
|---|---|
| Receipt number | R000054102 |
| Scientific Title | Japanese rehabilitation and risk factors on the post-intensive care syndrome study |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2023/12/04 10:04:58 |
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Basic information
Public title
Japanese rehabilitation and risk factors on the post-intensive care syndrome study
Acronym
J-RELIFE study
Scientific Title
Japanese rehabilitation and risk factors on the post-intensive care syndrome study
Scientific Title:Acronym
J-RELIFE study
Region
| Japan |
Condition
Condition
Critical illness
Classification by specialty
| Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between ICU-AW and PICS complications and rehabilitation during ICU admission in critically ill patients managed in the ICU.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PICS occurrence at three months after 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) On a ventilator for at least 48 hours
2) Patients who are 20 years of age or older at the time consent is obtained.
3) Patients who, after receiving a thorough explanation of the study and with full understanding, have given their or their surrogate's free written consent to participate in the study.
Key exclusion criteria
1) Patients discharged from the ICU within 48 hours (e.g., scheduled postoperative follow-up, dialysis only, etc.)
2)Diseases presenting with central nervous system disorders (stroke, severe head trauma, CNS infection, brain tumor, after neurosurgery, after cardiopulmonary resuscitation with hypoxic encephalopathy, cervical cord injury with impaired consciousness, cerebrovascular dementia, Alzheimer's disease, Parkinson's disease, etc.)
3)Patients who have difficulty communicating in Japanese or cooperating with rehabilitation, such as foreigners (including schizophrenia, anxiety, depression, autism, etc.)
4)Patients who could not walk even with the use of aids for walking before hospitalization (patients requiring nursing care 3 or more for services: approximate)
5) End of life/terminal care cases where treatment is not the objective.
6) Other patients who are deemed inappropriate by the principal investigator or research coordinator.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Nishida |
Organization
Fujita Health University
Division name
School of Medicine Anesthesiology & Critical Care Medicine
Zip code
470-1192
Address
98-1 Dengakugakubo, Kutsukakecho, Toyoakecity, Aichi
TEL
0562-93-2000
nishida@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | YUKI |
| Middle name | |
| Last name | IIDA |
Organization
Toyohashi SOZO University
Division name
School of health sciences
Zip code
440-8511
Address
20+1 Matsushita, Ushikawacho, Toyohashi-city, Aichi
TEL
050-2017-2266
Homepage URL
y-iida@sozo.ac.jp
Sponsor or person
Institute
Toyohashi SOZO University
Institute
Department
Personal name
Funding Source
Organization
Toyohashi SOZO University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Fujita Health University
Address
98-1 Dengakugakubo, Kutsukakecho, Toyoakecity, Aichi
Tel
0562-93-2865
crb-f@fujita-hu.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
| 2022 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
96
Results
Sixty-five patients were included in the analysis; HAD occurred in 21 patients, with significantly higher rates of motor function decline and frailty 3 months after discharge in the HAD group. The factors associated with the occurrence of HAD were grip strength at ICU discharge (OR, 0.91; 95% CI, 0.83-1.00; P=0.037) and the Functional Status Score for the ICU total (OR, 0.87; 95% CI, 0.76-1.00; P=0.036). HAD group presented with flail 3 months after discharge.
Results date posted
| 2023 | Year | 12 | Month | 04 | Day |
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Flow
(1)Record the rehabilitation and treatment provided to the research subjects in the usual medical care, as well as the data and laboratory values measured.
(2)After discharge from the ICU, physical function, mental function, and stress will be assessed.
(3 After discharge, a questionnaire survey on physical function, mental function, and stress will be conducted by mail.
(4)The frequency of outcome occurrence by ICU-AW complications and predictors of outcome occurrence at the time of discharge will be analyzed.
Management information
Registered date
| 2022 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054102
