UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043752 |
|---|---|
| Receipt number | 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 14:00:52 |
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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
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
ginga.suzuki@med.toho-u.ac.jp
Sponsor or person
Institute
Critical Care Center, Toho University Omori Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049948
