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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043752
Receipt No. R000049948
Scientific Title Nail fold capillary blood velocity measurement as a peripheral circulation evaluation in critically ill patients
Date of disclosure of the study information 2021/03/26
Last modified on 2021/03/26

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Basic information
Public title Nail fold capillary blood velocity measurement as a peripheral circulation evaluation in critically ill patients
Acronym Nail fold capillary blood velocity measurement as a peripheral circulation evaluation in critically ill patients
Scientific Title Nail fold capillary blood velocity measurement as a peripheral circulation evaluation in critically ill patients
Scientific Title:Acronym Nail fold capillary blood velocity measurement as a peripheral circulation evaluation in critically ill patients
Region
Japan

Condition
Condition critical illness
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether nail fold capillary blood velocity can predict organ failure.
Basic objectives2 Others
Basic objectives -Others To investigate whether nail fold capillary blood velocity correlates with changes in SOFA score after 48 hours.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between nail fold capillary blood velocity at admission and SOFA score change after 48 hours
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients expected to stay in ICU for 2 days or more
Patients who have obtained consent from the person or the representative
Key exclusion criteria ECMO patient
IMPELLA patient
DNAR patients
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ginga
Middle name
Last name Suzuki
Organization Toho University Omori medical Center
Division name Critical Care Center
Zip code 143-8541
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL 0337624151
Email ginga.suzuki@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Ginga
Middle name
Last name Suzuki
Organization Toho University Omori Medical Center
Division name Critical Care Center
Zip code 143-8541
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
TEL 0337624151
Homepage URL
Email ginga.suzuki@med.toho-u.ac.jp

Sponsor
Institute Critical Care Center, Toho University Omori Medical Center
Institute
Department

Funding Source
Organization None.
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 Toho University Omori Medical Center Review Board
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo, Japan
Tel 0357636534
Email omori.rinri@ext.toho-u.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
2021 Year 03 Month 26 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
2021 Year 03 Month 01 Day
Date of IRB
2021 Year 03 Month 23 Day
Anticipated trial start date
2021 Year 03 Month 26 Day
Last follow-up date
2024 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
2021 Year 03 Month 26 Day
Last modified on
2021 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049948

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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