UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045624 |
|---|---|
| Receipt number | R000052088 |
| Scientific Title | AAEM multicentre retrospective study |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/10/05 08:59:36 |
* 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
Investigation of the association between early rehabilitation and patient outcomes in intensive care units: a multicentre retrospective study
Acronym
Investigation of the association between early rehabilitation and patient outcomes in intensive care units: a multicentre retrospective study
Scientific Title
AAEM multicentre retrospective study
Scientific Title:Acronym
AAEM multicentre retrospective study
Region
| Japan |
Condition
Condition
ICU patients
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the relationship between PICS and patient outcomes using the Euro QOL 5 Dimension (EQ-5D-5L) as a surrogate outcome by investigating the actual release (frequency and intensity) in a multi-centre setting where standard rehabilitation is provided.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Euro-QOL at discharge from hospital (EQ-5D-5L)
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients admitted to the ICU in a certain 2-month period
Key exclusion criteria
(1) Under 18 years old
2) Patients who are expected to be discharged from ICU within 48 hours (e.g., follow-up after scheduled surgery, dialysis only)
3) Diseases presenting central nervous system disorder (stroke, severe head injury, central nervous system infection, brain tumor, after brain surgery, after cardiopulmonary resuscitation with hypoxic encephalopathy, cervical cord injury with consciousness disorder, cerebrovascular dementia, Alzheimer's disease, Parkinson's disease, etc.)
(4) Patients who have difficulty in communicating in Japanese and cooperating in rehabilitation, such as foreigners (including schizophrenia, anxiety neurosis, depression, autism, etc.)
(5) Patients who were unable to walk even with the use of assistive devices before admission (using services requiring nursing care 3 or more: standard)
6) End of life/Terminal care cases where treatment is not the aim
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Fujizuka |
Organization
Japan Red Cross Maebashi Hospital
Division name
Advanced Medical Emergency Department and Critical Care Center
Zip code
371-0811
Address
389-1 Asakura-cho, Maebashi-shi, Gunma
TEL
+81272653333
fujiken_sanjo_4138@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Fujizuka |
Organization
Japan Red Cross Maebashi Hospital
Division name
Advanced Medical Emergency Department and Critical Care Center
Zip code
371-0811
Address
389-1 Asakura-cho, Maebashi-shi, Gunma
TEL
+81272653333
Homepage URL
fujiken_sanjo_4138@yahoo.co.jp
Sponsor or person
Institute
Japan Red Cross Maebashi Hospital
Advanced Medical Emergency Department and Critical Care Center
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Red Cross Maebashi Hospital
Address
389-1 Asakura-cho, Maebashi-shi, Gunma
Tel
+81 27-265-3333
fujiken_sanjo_4138@yahoo.co.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
| 2021 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
not available
Publication of results
Unpublished
Result
URL related to results and publications
not available
Number of participants that the trial has enrolled
200
Results
Under analysis
Results date posted
| 2021 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Under analysis
Participant flow
Under analysis
Adverse events
Under analysis
Outcome measures
Under analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular at this moment
Management information
Registered date
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052088
