UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054393 |
|---|---|
| Receipt number | R000062130 |
| Scientific Title | JPICS database |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/11/15 19:14:41 |
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Basic information
Public title
Japanese Post-Intensive Care Syndrome (JPICS) database
Acronym
JPICS database
Scientific Title
JPICS database
Scientific Title:Acronym
JPICS database
Region
| Japan |
Condition
Condition
Patients admitted to intensive care unit
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the long-term prognosis and quality of life of critically ill patients admitted to ICU in Japan and to determine the presence of mental disorders in the families of critically ill patients.
Basic objectives2
Others
Basic objectives -Others
To determine the long-term prognosis and quality of life of critically ill patients admitted to ICU in Japan and to determine the presence of mental disorders in the families of critically ill patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Patient side]
Prevalence of post-intensive care syndrome at 3, 6 and 12 months after ICU discharge.
[Family side]
Prevalence of mental disorders at 3, 6 and 12 months after ICU 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[Patient side]
Patients admitted to the intensive care unit
Aged 16 years and over at the time of registration.
[Family members]
Family member of a patient admitted to the intensive care unit (third degree of kinship, key person in principle)
Family members aged 16 years and over at the time of registration
Key exclusion criteria
[Patient/family side]
Research subjects who refused when asked to register their personal data using the 'Notice on the Epidemiological Study of Post-intensive Care Syndrome'.
Research subjects who have checked the "Do not agree" box after reviewing the research instructions distributed via SMS online.
Other research subjects whom the principal investigator or physician in charge considers unsuitable for the safe conduct of this research.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Hatakeyama |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
junji.hatakeyama@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Hatakeyama |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
569-8686
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
junji.hatakeyama@ompu.ac.jp
Sponsor or person
Institute
Japanese Society of Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Medical Research Specialist Group, Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
Tel
072-683-1221
rinri@ompu.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
| 2024 | Year | 06 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Post-intensive care syndrome (PICS) refers to physical, cognitive and mental disorders that develop in critically ill patients during, after or after discharge from intensive care units (ICUs), including mental disorders in their families ( It has been reported from other countries that the onset of PICS has a significant impact on patients and their families, as well as being a major burden on healthcare economics. However, no large-scale epidemiological study of PICS has been conducted in Japan, and there is a need for the establishment of basic data to promote PICS research. Therefore, the Japanese PostIntensive Care Syndrome (JPICS) database was developed as a committee activity of the PICS Countermeasures and Quality of Life Improvement Study Committee of the Japanese Society of Intensive Care Medicine, based on the 2021 Clinical Effect Database Development Project grant. The University is the lead institution for this JPICS database project and will continue to conduct semi-permanent epidemiological surveys of seriously ill patients and their families.
Management information
Registered date
| 2024 | Year | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062130
