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

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 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

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

Value
https://center6.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