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

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 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

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

Value
https://center6.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