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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022929
Receipt No. R000026419
Scientific Title Cardiomyopathy in Sepsis
Date of disclosure of the study information 2016/07/01
Last modified on 2019/10/04

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Basic information
Public title Cardiomyopathy in Sepsis
Acronym Cardiomyopathy in Sepsis
Scientific Title Cardiomyopathy in Sepsis
Scientific Title:Acronym Cardiomyopathy in Sepsis
Region
Japan

Condition
Condition Sepsis
Classification by specialty
Cardiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine myocardial damage in sepsis
Basic objectives2 Others
Basic objectives -Others Prognosis of the septic patients with cardiomyopathy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum troponin I consentration at the onset
Key secondary outcomes Serum concentration of BNP (Brain Natriuretic Peptide), CPK, thrombomodulin, and cardiac function examination using echocardiography, arrhythmia, hemodiafiltration, operaton, amount of bleeding and prognosis

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 Septic patients
Key exclusion criteria under 18 years old
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Ogura
Organization Gifu University Hospital
Division name Advanced Critical Care Center
Zip code 501-1194
Address 1-1 Yanagido, Gifu, Gifu
TEL 058-230-6448
Email oguras@gifu-u.ac.jp

Public contact
Name of contact person
1st name Hideshi
Middle name
Last name Okada
Organization Gifu University Hospital
Division name Advanced Critical Care Center
Zip code 5011194
Address 1-1 Yanagido, Gifu, Gifu
TEL 058-230-6448
Homepage URL
Email hideshi@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization Self funding
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 The ethics committee of the Gifu University Graduate School of Medicine
Address 1-1 Yanagido, Gifu, Gifu
Tel 0582306059
Email gjme00004@jim.gifu-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
2016 Year 07 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 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 06 Month 28 Day
Last modified on
2019 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026419

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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