UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043448 |
|---|---|
| Receipt number | R000049615 |
| Scientific Title | A retrospective observational study of long-term prognosis and factors associated with long-term prognosis in patients admitted to the ICU |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2022/08/29 09:57:41 |
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Basic information
Public title
A retrospective observational study of ICU admitted patients long-term prognosis and its related factors
Acronym
ICU admitted patients long-term prognosis study
Scientific Title
A retrospective observational study of long-term prognosis and factors associated with long-term prognosis in patients admitted to the ICU
Scientific Title:Acronym
ICU admitted patients long-term prognosis study
Region
| Japan |
Condition
Condition
ICU admitted patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By now, evaluation of the effectiveness of treatment in the ICU focused on relatively short-term prognosis, such as survival rate in the ICU and survival rate at 28 days, but with advances in ICU treatment methods, attention has been focused on the long-term prognosis of patients in the ICU and factors related to that prognosis. It is also important to maintain ADL after ICU discharge. However, although there are some reports on these issues, they are still rare. The purpose of this study was to investigate the prognosis of patients admitted to the ICU at 6 and 12 months and to identify factors associated with long-term prognosis. Furthermore, by predicting the long-term prognosis before admission to the ICU, we aim to realize the appropriate use of the ICU.
Basic objectives2
Others
Basic objectives -Others
analysis of long-term prognosis and its related factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL (Barthel score) at 6 months after the day of ICU admission
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
ICU admitted patients
Key exclusion criteria
age
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666 Japan
TEL
03-3353-8111
mnmanta@gmail.com
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666 Japan
TEL
03-3353-8111
Homepage URL
mnmanta@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666 Japan
Tel
03-3353-8111
mnmanta@gmail.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 | 03 | Month | 01 | 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
0
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
Terminated
Date of protocol fixation
| 2021 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | 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
none
Management information
Registered date
| 2021 | Year | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049615
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
