UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043864 |
|---|---|
| Receipt number | R000049072 |
| Scientific Title | International Survey to Investigate the implementation of evidence-based ICU Care during the COVID-19 pandemic An international one day point prevalence study -ISIIC 2 Study- |
| Date of disclosure of the study information | 2021/04/07 |
| Last modified on | 2021/04/07 22:58:46 |
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Basic information
Public title
International survey to investigate the implementation of daily ICU care for patients with and without COVID-19 infection.
A Point Prevalence Study -ISIIC 2 Study-
Acronym
ISIIC 2 Study
Scientific Title
International Survey to Investigate the implementation of evidence-based ICU Care during the COVID-19 pandemic An international one day point prevalence study
-ISIIC 2 Study-
Scientific Title:Acronym
ISIIC 2 Study
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
patients in ICU
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the implementation of evidence-based ICU care, such as ABCDEF bundle, nutrition, ICU diary, and physical restriction to both patients with and without COVID-19 infection
Basic objectives2
Others
Basic objectives -Others
To compare the implementation rate of evidenced-based care between low, middle, and high income countries.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The implementation rate of the ABCDEF bundle as each element or an entire of the bindle
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All ICU patients who stay in the participating ICUs on the survey date
Key exclusion criteria
patients in a terminal state and receiving palliative care
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Keibun |
| Middle name | |
| Last name | Liu |
Organization
The Prince Charles Hospital
Division name
Critical Care Research Group
Zip code
4032
Address
627 Rode Rd, Chermside
TEL
080-4790-7701
keiliu0406@gmail.com
Public contact
Name of contact person
| 1st name | Keibun |
| Middle name | |
| Last name | Liu |
Organization
The Prince Charles Hospital
Division name
Critical Care Research Group
Zip code
4032
Address
627 Rode Rd, Chermside
TEL
080-4790-7701
Homepage URL
keiliu0406@gmail.com
Sponsor or person
Institute
Saiseikai Utsunomiya Hospital
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Saiseikai Utsunomiya Hospital
Address
911-1, takebayashi cho, Utsunomiya shi, Tochigi, 3210974
Tel
028-626-5500
keiliu0406@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 | 04 | Month | 07 | 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
1229
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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
One day point prevalence study
Ths survey was conducted already
Now on analysis
The registration of this study on the list was definitely pre-survey.
Management information
Registered date
| 2021 | Year | 04 | Month | 07 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049072
