UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042158 |
|---|---|
| Receipt number | R000048121 |
| Scientific Title | An observational study for prevalence of post-intensive care syndrome in patients and their families after ICU treatment and the identification of possibilities for prevention and treatment. |
| Date of disclosure of the study information | 2020/10/19 |
| Last modified on | 2020/10/19 10:16:28 |
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Basic information
Public title
An observational study for prevalence of post-intensive care syndrome in patients and their families after ICU treatment and the identification of possibilities for prevention and treatment.
Acronym
An observational study for epidemiology and treatment strategy for PICS
Scientific Title
An observational study for prevalence of post-intensive care syndrome in patients and their families after ICU treatment and the identification of possibilities for prevention and treatment.
Scientific Title:Acronym
An observational study for epidemiology and treatment strategy for PICS
Region
| Japan |
Condition
Condition
Adult ICU patients
Classification by specialty
| Emergency medicine | Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at describing the prevalence of post-ICU syndrome (PICS) in patients treated under limited family contact, using patient information and questionnaires. The study will continue after family visits are freed, and will observer the difference between the two phases. the study will also attempt to identify possible prevention strategy for PICS.
Basic objectives2
Others
Basic objectives -Others
study of epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of limited family visits on the prevalence of PICS
Key secondary outcomes
The overall prevalence of PICS in ICU patients
The effect of severity and treatment on the occurrence of PICS
The effect of family involvement on PICS
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. Age 20 years and older
2. ICU treatment more than 3 days
Key exclusion criteria
1. age under 20 years
2. less than 3 days in ICU
3. patients after elective surgery
4. others decided by investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Taka-aki |
| Middle name | |
| Last name | Nakada |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba City, Chiba
TEL
043-226-2341
chibadaieccm-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Oshima |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba City, Chiba
TEL
043-226-2341
Homepage URL
t_oshima@chiba-u.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
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
Institutional Review Board, Chiba University Graduate School of Medicine
Address
1-8-1 Inohana Chuo-ku, Chiba City, Chiba
Tel
043-222-7171
inohana-rinri@chiba-u.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
| 2020 | Year | 10 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 12 | 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
| 2020 | Year | 10 | Month | 19 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048121
