UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022929 |
|---|---|
| Receipt number | R000026419 |
| Scientific Title | Cardiomyopathy in Sepsis |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2019/10/04 13:52:16 |
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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
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
hideshi@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026419
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
