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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025296
Receipt No. R000029096
Scientific Title Acute Heart Failure and Vascular Endothelial Glycocalyx Injury
Date of disclosure of the study information 2016/12/15
Last modified on 2017/11/22

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Basic information
Public title Acute Heart Failure and Vascular Endothelial Glycocalyx Injury
Acronym Vascular Endothelial Glycocalyx Injury in Heart Failure
Scientific Title Acute Heart Failure and Vascular Endothelial Glycocalyx Injury
Scientific Title:Acronym Vascular Endothelial Glycocalyx Injury in Heart Failure
Region
Japan

Condition
Condition Acute Heart Failure
Classification by specialty
Cardiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the relation between Glycocalyx injury and outcome of acute heart failure
Basic objectives2 Others
Basic objectives -Others To confirm the relation between Glycocalyx injury and outcome of acute heart failure
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes prognosis and termination of the patients
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria The patients who admitted to Advanced Critical Care Center of our hospital due to acute heart failure
Key exclusion criteria The patients who are Under 20 years-old
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Ushikoshi
Organization Gifu University Hospital
Division name Advanced Critical Care Center
Zip code
Address 1-1 Yanagido, Gifu, Japan
TEL 058-230-6448
Email hiroakiu@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideshi Okada
Organization Gifu University Hospital
Division name Advanced Critical Care Center
Zip code
Address 1-1 Yanagido, Gifu, Japan
TEL 058-230-6448
Homepage URL
Email hideshi@gifu-u.ac.jp

Sponsor
Institute Advanced Critical Care Center, Gifu University Hospital
Institute
Department

Funding Source
Organization Advanced Critical Care Center, Gifu University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 Month 15 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
2016 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 12 Month 15 Day
Last modified on
2017 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029096

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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