UMIN-CTR Clinical Trial

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
Email	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
Email	mnmanta@gmail.com

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049615