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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043864
Receipt No. 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

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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
Email 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
Email keiliu0406@gmail.com

Sponsor
Institute Saiseikai Utsunomiya Hospital
Hitachi General Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049072

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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